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270<content-item-title></content-item-title>
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279                            <img alt="Finding the hidden costs-GettyImages-1478035639" class="lazyload vm-image img-responsive" data-sizes="(max-width: 576px) 360px,510px" data-src="https://vertassets.blob.core.windows.net/image/eb9e1010/eb9e1010-8b50-4914-b13c-a59be94e9eba/510_340-finding_the_hidden_costs_gettyimages_1478035639.jpg" data-srcset="https://vertassets.blob.core.windows.net/image/eb9e1010/eb9e1010-8b50-4914-b13c-a59be94e9eba/360_240-finding_the_hidden_costs_gettyimages_1478035639.jpg 360w,https://vertassets.blob.core.windows.net/image/eb9e1010/eb9e1010-8b50-4914-b13c-a59be94e9eba/510_340-finding_the_hidden_costs_gettyimages_1478035639.jpg 510w" title="DEA Reveals Hidden Costs Of Analytical Validation Guidelines" />
280                        </a>
281                    </div>
282                <a href="/doc/dea-reveals-hidden-costs-of-analytical-validation-guidelines-0001" class="feature-link">DEA Reveals Hidden Costs Of Analytical Validation Guidelines</a>
283                <div class="summary ellipsis"><p>By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.</p>
284</div>
285            </div>
286
287            <ul class="secondary list-unstyled clearfix">
288                    <li>
289                            <div class="img-canvas">
290                                <a href="/doc/qualification-and-validation-of-depyrogenation-tunnels-and-autoclaves-0001">
291                                    <img alt="Quality assurance, approved network-GettyImages-2247428372" class="lazyload vm-image img-responsive mobile-hide" data-src="https://vertassets.blob.core.windows.net/image/d86127b7/d86127b7-fbd7-4400-aeed-8c22a9291645/245_163-quality_assurance__approved_network_gettyimages_2247428372.jpg" title="Qualification And Validation Of Depyrogenation Tunnels And Autoclaves" />
292                                </a>
293                                <a href="/doc/qualification-and-validation-of-depyrogenation-tunnels-and-autoclaves-0001" class="feature-link">Qualification And Validation Of Depyrogenation Tunnels And Autoclaves</a>
294                            </div>
295                    </li>
296                    <li>
297                            <div class="img-canvas">
298                                <a href="/doc/fda-modernizes-container-closure-guidance-what-is-changing-and-why-it-matters-0001">
299                                    <img alt="FDA-GettyImages-2271213876" class="lazyload vm-image img-responsive mobile-hide" data-src="https://vertassets.blob.core.windows.net/image/2f8bab6b/2f8bab6b-c081-432b-b806-d6653f577883/245_163-fda_gettyimages_2271213876.jpg" title="FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters" />
300                                </a>
301                                <a href="/doc/fda-modernizes-container-closure-guidance-what-is-changing-and-why-it-matters-0001" class="feature-link">FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters</a>
302                            </div>
303                    </li>
304            </ul>
305        </div>
306
307        <div class="right mobile-hide">
308            <ul class="list-unstyled">
309                    <li>
310                        <a href="/doc/you-can-t-capa-what-you-can-t-classify-0001" class="feature-link">You Can't CAPA What You Can't Classify</a>
311                    </li>
312                    <li>
313                        <a href="/doc/modeling-approaches-that-make-complex-bioprocess-data-useful-0001" class="feature-link">6 Modeling Approaches That Make Complex Bioprocess Data Useful</a>
314                    </li>
315                    <li>
316                        <a href="/doc/building-trust-in-ai-for-computerized-system-validation-0001" class="feature-link">Building Trust In AI For Computerized System Validation</a>
317                    </li>
318                    <li>
319                        <a href="/doc/a-gentler-cell-line-selection-method-using-microrna-0001" class="feature-link">A Gentler Cell Line Selection Method Using microRNA</a>
320                    </li>
321                    <li>
322                        <a href="/doc/controls-for-retrieval-augmented-generation-in-gxp-0001" class="feature-link">Controls For Retrieval-Augmented Generation In GxP</a>
323                    </li>
324                    <li>
325                        <a href="/doc/implementing-ai-solutions-in-gmp-while-managing-risk-0001" class="feature-link">Implementing AI Solutions In GMP While Managing Risk</a>
326                    </li>
327                    <li>
328                        <a href="/doc/implementing-and-optimizing-your-eqms-0001" class="feature-link">Implementing And Optimizing Your eQMS</a>
329                    </li>
330            </ul>
331        </div>
332    </div>
333
334
335    </div>
336    <div class="vm-content-item vm-bucket vm-skipcontent">
337
338<h2 class="vm-section-header">GUEST COLUMNISTS</h2>
339<h6></h6>
340
341        
342<ul class="separated-items list-unstyled">
343        <li class="image-title-summary-container row no-gutters align-items-start">
344                <div class="col-auto pt-3 pr-3 mobile-hide">
345                    <div class="img-canvas">
346                        <a href="/doc/you-can-t-capa-what-you-can-t-classify-0001">
347                            <img alt="CAPA effectiveness-GettyImages-2283083181" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/0af84470/0af84470-5b29-406b-a441-450971fa90ca/150_100-capa_effectiveness_gettyimages_2283083181.jpg" title="You Can&#x27;t CAPA What You Can&#x27;t Classify" />
348                        </a>
349                    </div>
350                </div>
351
352            <div class="col pt-3">
353                <div class="summary ellipsis">
354                    <a href="/doc/you-can-t-capa-what-you-can-t-classify-0001" title="You Can't CAPA What You Can't Classify" class="title-link">
355                        You Can't CAPA What You Can't Classify
356                    </a>
357                    
358                    <p>An LLM or agentic error can occur with no component broken in any way the QMS recognizes.&nbsp;Classifying it takes two fields: the error type and the error origination point.</p>
359
360                </div>
361            </div>
362        </li>
363        <li class="image-title-summary-container row no-gutters align-items-start">
364                <div class="col-auto pt-3 pr-3 mobile-hide">
365                    <div class="img-canvas">
366                        <a href="/doc/modeling-approaches-that-make-complex-bioprocess-data-useful-0001">
367                            <img alt="complex messy management, bureaucracy,red tape,organization, communication problems,business disruption-GettyImages-2262947509" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/562c2227/562c2227-0de0-4153-96e7-a3c16314ef72/150_100-complex_messy_management__bureaucracy_red_tape_organization__communication_problems_business_disruption_gettyimages_2262947509.jpg" title="6 Modeling Approaches That Make Complex Bioprocess Data Useful" />
368                        </a>
369                    </div>
370                </div>
371
372            <div class="col pt-3">
373                <div class="summary ellipsis">
374                    <a href="/doc/modeling-approaches-that-make-complex-bioprocess-data-useful-0001" title="6 Modeling Approaches That Make Complex Bioprocess Data Useful" class="title-link">
375                        6 Modeling Approaches That Make Complex Bioprocess Data Useful
376                    </a>
377                    
378                    <p>AI algorithms can reduce data dimensionality more faithfully by interpreting multivariate features relevant to prediction or control.</p>
379
380                </div>
381            </div>
382        </li>
383        <li class="image-title-summary-container row no-gutters align-items-start">
384                <div class="col-auto pt-3 pr-3 mobile-hide">
385                    <div class="img-canvas">
386                        <a href="/doc/building-trust-in-ai-for-computerized-system-validation-0001">
387                            <img alt="Artifical intelligence, future concept-GettyImages-1166228181" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/ba64eada/ba64eada-22be-4fba-8283-ab3aa7b399c8/150_100-artifical_intelligence__future_concept_gettyimages_1166228181.jpg" title="Building Trust In AI For Computerized System Validation" />
388                        </a>
389                    </div>
390                </div>
391
392            <div class="col pt-3">
393                <div class="summary ellipsis">
394                    <a href="/doc/building-trust-in-ai-for-computerized-system-validation-0001" title="Building Trust In AI For Computerized System Validation" class="title-link">
395                        Building Trust In AI For Computerized System Validation
396                    </a>
397                    
398                    <p>Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it&#39;
398s not the same, namely, there are no subjective judgment calls.</p>
399
400                </div>
401            </div>
402        </li>
403        <li class="image-title-summary-container row no-gutters align-items-start">
404                <div class="col-auto pt-3 pr-3 mobile-hide">
405                    <div class="img-canvas">
406                        <a href="/doc/a-gentler-cell-line-selection-method-using-microrna-0001">
407                            <img alt="GettyImages-1295693748-mRNA-strand" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/2be24e00/2be24e00-ae41-4f7e-b2f1-1abe71e13689/150_100-gettyimages_1295693748_mrna_strand.jpg" title="A Gentler Cell Line Selection Method Using microRNA" />
408                        </a>
409                    </div>
410                </div>
411
412            <div class="col pt-3">
413                <div class="summary ellipsis">
414                    <a href="/doc/a-gentler-cell-line-selection-method-using-microrna-0001" title="A Gentler Cell Line Selection Method Using microRNA" class="title-link">
415                        A Gentler Cell Line Selection Method Using microRNA
416                    </a>
417                    
418                    <p>Traditional selection stresses surviving cells. New research shows how structurally interacting RNA may use endogenous microRNA for a faster, nontoxic selection process.</p>
419
420                </div>
421            </div>
422        </li>
423        <li class="image-title-summary-container row no-gutters align-items-start">
424                <div class="col-auto pt-3 pr-3 mobile-hide">
425                    <div class="img-canvas">
426                        <a href="/doc/controls-for-retrieval-augmented-generation-in-gxp-0001">
427                            <img alt="data search, information discovery, file management, digital analysis, and advanced data retrieval systems-GettyImages-2284270263" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/aaa30c5e/aaa30c5e-aed3-4178-9a98-de0c5cd848ee/150_100-data_search__information_discovery__file_management__digital_analysis__and_advanced_data_retrieval_systems_gettyimages_2284270263.jpg" title="Controls For Retrieval-Augmented Generation In GxP" />
428                        </a>
429                    </div>
430                </div>
431
432            <div class="col pt-3">
433                <div class="summary ellipsis">
434                    <a href="/doc/controls-for-retrieval-augmented-generation-in-gxp-0001" title="Controls For Retrieval-Augmented Generation In GxP" class="title-link">
435                        Controls For Retrieval-Augmented Generation In GxP
436                    </a>
437                    
438                    <p>Validation teams deal with inherent variability all the time. The same principles for GMP &mdash; think visual inspection &mdash; can apply to probabilistic AI systems.</p>
439
440                </div>
441            </div>
442        </li>
443        <li class="image-title-summary-container row no-gutters align-items-start">
444                <div class="col-auto pt-3 pr-3 mobile-hide">
445                    <div class="img-canvas">
446                        <a href="/doc/implementing-ai-solutions-in-gmp-while-managing-risk-0001">
447                            <img alt="digital research, biotech, scientific innovation-GettyImages-2223712673" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/061318a8/061318a8-d4d7-4659-81bf-e8da45f0d4d6/150_100-digital_research__biotech__scientific_innovation_gettyimages_2223712673.jpg" title="Implementing AI Solutions In GMP While Managing Risk" />
448                        </a>
449                    </div>
450                </div>
451
452            <div class="col pt-3">
453                <div class="summary ellipsis">
454                    <a href="/doc/implementing-ai-solutions-in-gmp-while-managing-risk-0001" title="Implementing AI Solutions In GMP While Managing Risk" class="title-link">
455                        Implementing AI Solutions In GMP While Managing Risk
456                    </a>
457                    
458                    <p>When using artificial intelligence in GMP settings, risk management extends far beyond &nbsp;
458validation. This discussion explores moving AI solutions out of the pilot phase.</p>
459
460                </div>
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466                        <a href="/doc/implementing-and-optimizing-your-eqms-0001">
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468                        </a>
469                    </div>
470                </div>
471
472            <div class="col pt-3">
473                <div class="summary ellipsis">
474                    <a href="/doc/implementing-and-optimizing-your-eqms-0001" title="Implementing And Optimizing Your eQMS" class="title-link">
475                        Implementing And Optimizing Your eQMS
476                    </a>
477                    
478                    <p>This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.</p>
479
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491<h2 class="vm-section-header">BIOSIMILAR WHITE PAPERS</h2>
492<h6></h6>
493
494        
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496        <li class="image-title-summary-container row no-gutters align-items-start">
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499                        <a href="/doc/economic-advantage-of-robotic-gloveless-pharmaceutical-isolators-0001">
500                            <img alt="GettyImages-1470034194-magnifying-glass-charts-calculator" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/f93112bf/f93112bf-815e-43ac-89cc-d366c3cad507/150_100-gettyimages_1470034194_magnifying_glass_charts_calculator.jpg" title="Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators" />
501                        </a>
502                    </div>
503                </div>
504
505            <div class="col pt-3">
506                <div class="summary ellipsis">
507                    <a href="/doc/economic-advantage-of-robotic-gloveless-pharmaceutical-isolators-0001" title="Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators" class="title-link">
508                        Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators
509                    </a>
510                    
511                    <p>Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.</p>
512
513                </div>
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516</ul>
517        
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520            <div class="summary ellipsis">
521                <a href="/doc/optimizing-safety-measures-for-raav-therapies-0001" title="Optimizing Safety Measures For rAAV Therapies" class="title-link">
522                    Optimizing Safety Measures For rAAV Therapies
523                </a>
524                <div style="padding-bottom: 5px">
525                      <em class="vm-hub-date">
526                           10/11/2024
527                      </em>
528                </div>
529                <span class="mobile-hide"><p>Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.</p>
530</span>
531            </div>
532        </li>
533        <li class="image-title-summary-container">
534            <div class="summary ellipsis">
535                <a href="/doc/adventitious-agent-testing-by-ngs-a-comprehe
535nsive-solution-with-targeted-and-non-targeted-methods-0001" title="A Comprehensive Solution For Adventitious Agent Testing" class="title-link">
536                    A Comprehensive Solution For Adventitious Agent Testing
537                </a>
538                <div style="padding-bottom: 5px">
539                      <em class="vm-hub-date">
540                           2/13/2026
541                      </em>
542                </div>
543                <span class="mobile-hide"><p>Modern sequencing methods offer sensitive detection of adventitious and species‑specific viruses. Learn how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.</p>
544</span>
545            </div>
546        </li>
547        <li class="image-title-summary-container">
548            <div class="summary ellipsis">
549                <a href="/doc/why-choose-robotic-processing-for-small-batch-aseptic-filling-0001" title="Why Choose Robotic Processing For Small Batch Aseptic Filling" class="title-link">
550                    Why Choose Robotic Processing For Small Batch Aseptic Filling
551                </a>
552                <div style="padding-bottom: 5px">
553                      <em class="vm-hub-date">
554                           1/9/2026
555                      </em>
556                </div>
557                <span class="mobile-hide"><p>Reducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it&rsquo;s transforming sterile drug manufacturing.</p>
558</span>
559            </div>
560        </li>
561        <li class="image-title-summary-container">
562            <div class="summary ellipsis">
563                <a href="/doc/assessing-the-blazar-cho-aof-assay-against-traditional-in-vitro-testing-for-adventitious-virus-detection-0001" title="Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection" class="title-link">
564                    Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection
565                </a>
566                <div style="padding-bottom: 5px">
567                      <em class="vm-hub-date">
568                           10/3/2024
569                      </em>
570                </div>
571                <span class="mobile-hide"><p>Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.</p>
572</span>
573            </div>
574        </li>
575        <li class="image-title-summary-container">
576            <div class="summary ellipsis">
577                <a href="/doc/rethink-cell-therapy-how-lipid-nanoparticles-enable-next-gen-delivery-0001" title="How Lipid Nanoparticles Enable Next-Gen Delivery" class="title-link">
578                    How Lipid Nanoparticles Enable Next-Gen Delivery
579                </a>
580                <div style="padding-bottom: 5px">
581                      <em class="vm-hub-date">
582                           10/20/2025
583                      </em>
584                </div>
585                <span class="mobile-hide"><p>Cell therapy&rsquo;s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.</p>
586</span>
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597
598<h2 class="vm-section-header">BIOSIMILAR APP NOTES &amp; CASE STUDIES</h2>
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604            <a href="/doc/cell-culture-media-filtration-evaluating-cell-culture-performance-0001" title="Cell Culture Media Filtration: Evaluating Cell Culture Performance" class="title-link">
605                Cell Culture Media Filtration: Evaluating Cell Culture Performance
606            </a>
607        </li>
608        <li class="title-link-container">
609            <a href="/doc/multi-column-chromatography-for-efficient-polishing-purification-0001" title="Multi-Column Chromatography For Efficient Polishing Purification" class="title-link">
610                Multi-Column Chromatography For Efficient Polishing Purification
611            </a>
612        </li>
613        <li class="title-link-container">
614            <a href="/doc/optimizing-tff-and-sptff-for-high-concentration-mab-formulations-0001" title="Optimizing TFF And SPTFF For High-Concentration mAb Formulations" class="title-link">
615                Optimizing TFF And SPTFF For High-Concentration mAb Formulations
616            </a>
617        </li>
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619            <a href="/doc/cdmo-uses-robotic-gloveless-isolator-for-advanced-therapeutics-0001" title="CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics" class="title-link">
620                CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics
621            </a>
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624            <a href="/doc/cell-culture-media-mixing-in-a-benchtop-levmixer-single-use-mixer-0001" title="Cell Culture Media Mixing In A Benchtop Single-Use Mixer" class="title-link">
625                Cell Culture Media Mixing In A Benchtop Single-Use Mixer
626            </a>
627        </li>
628</ul>
629
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729    
730
731    <img alt="20_06_BSD_ComparativeEfficacy_Ebook_300x200" class="lazyload vm-image" data-src="https://vertassets.blob.core.windows.net/image/e509a3a4/e509a3a4-c766-453e-97d7-7ed2020251e2/20_06_bsd_comparativeefficacy_ebook_300x200.jpg" title="20_06_BSD_ComparativeEfficacy_Ebook_300x200" />
732
733<p>&nbsp;</p>
734
735<p>The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. <a href="https://www.bi
735osimilardevelopment.com/doc/biosimilar-comparative-efficacy-studies-an-evolving-debate-promotion-0001">This collection of articles</a> serves as a snapshot of the many different components of this ongoing discussion.</p>
736
737
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743<h2 class="vm-section-header">BIOSIMILAR DEVELOPMENT NEWS</h2>
744<h6></h6>
745
746        
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749            <a href="/doc/waltz-health-and-fresenius-kabi-expand-direct-access-to-biosimilars-through-waltz-connect-platform-0001" title="Waltz Health And Fresenius Kabi Expand Direct Access To Biosimilars Through Waltz Connect Platform" class="title-link">
750                Waltz Health And Fresenius Kabi Expand Direct Access To Biosimilars Through Waltz Connect Platform
751            </a>
752        </li>
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754            <a href="/doc/the-biosimilars-forum-strongly-supports-fda-s-bsufa-iv-agreement-to-strengthen-biosimilar-development-0001" title="The Biosimilars Forum Strongly Supports FDA's BsUFA IV Agreement To Strengthen Biosimilar Development And Review" class="title-link">
755                The Biosimilars Forum Strongly Supports FDA's BsUFA IV Agreement To Strengthen Biosimilar Development And Review
756            </a>
757        </li>
758        <li class="title-link-container">
759            <a href="/doc/sandoz-opens-advanced-high-volume-drug-substance-manufacturing-centre-in-lendava-significantly-strengthening-0001" title="Sandoz Opens Advanced High-Volume Drug Substance Manufacturing Centre In Lendava, Significantly Strengthening In-House Capacity And Flexibility Across Leading European Biosimilar Network" class="title-link">
760                Sandoz Opens Advanced High-Volume Drug Substance Manufacturing Centre In Lendava, Significantly Strengthening In-House Capacity And Flexibility Across Leading European Biosimilar Network
761            </a>
762        </li>
763        <li class="title-link-container">
764            <a href="/doc/stada-and-sbp-group-launch-strategic-biosimilars-partnership-including-a-biosimilar-to-keytruda-0001" title="STADA And SBP Group Launch Strategic Biosimilars Partnership, Including A Biosimilar To Keytruda" class="title-link">
765                STADA And SBP Group Launch Strategic Biosimilars Partnership, Including A Biosimilar To Keytruda
766            </a>
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768        <li class="title-link-container">
769            <a href="/doc/meitheal-pharmaceuticals-announces-fda-approval-of-high-concentration-formulation-of-yusimry-a-biosimilar-to-humira-0001" title="Meitheal Pharmaceuticals Announces FDA Approval Of High-Concentration Formulation Of YUSIMRY, A Biosimilar To Humira" class="title-link">
770                Meitheal Pharmaceuticals Announces FDA Approval Of High-Concentration Formulation Of YUSIMRY, A Biosimilar To Humira
771            </a>
772        </li>
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774            <a href="/doc/teva-continues-biosimilar-momentum-with-u-s-fda-approval-of-degevma-denosumab-adet-a-biosimilar-to-xgeva-denosumab-0001" title="Teva Continues Biosimilar Momentum With U.S. FDA Approval Of DEGEVMA&trade; (denosumab-adet), A Biosimilar To Xgeva&reg; (denosumab)" class="title-link">
775                Teva Continues Biosimilar Momentum With U.S. FDA Approval Of DEGEVMA&trade; (denosumab-adet), A Biosimilar To Xgeva&reg; (denosumab)
776            </a>
777        </li>
778        <li class="title-link-container">
779            <a href="/doc/aam-and-biosimilars-council-comment-on-gdufa-and-bsufa-user-fee-negotiations-and-reauthorization-0001" title="AAM And Biosimilars Council Comment On GDUFA And BsUFA User Fee Negotiations And Reauthorization" class="title-link">
780                AAM And Biosimilars Council Comment On GDUFA And BsUFA User Fee Negotiations And Reauthorization
781            </a>
782        </li>
783        <li class="title-link-container">
784            <a href="/doc/phrma-statement-on-the-biosimilar-user-fee-act-bsufa-iv-performance-goals-letter-0001" title="PhRMA Statement On The Biosimilar User Fee Act (BsUFA) IV Performance Goals Letter" class="title-link">
785                PhRMA Statement On The Biosimilar User Fee Act (BsUFA) IV Performance Goals Letter
786            </a>
787        </li>
788</ul>
789
790
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803            <a href="/doc/faster-paths-to-biosimilar-equivalence-0001" title="10.01.26 -- Faster Paths To Biosimilar Equivalence" class="title-link">
804                10.01.26 -- Faster Paths To Biosimilar Equivalence
805            </a>
806        </li>
807        <li class="title-link-container">
808            <a href="/doc/general-nl-10918" title="09.24.26 -- Navigating The Regulatory 
808Space To Biosimilar Approval" class="title-link">
809                09.24.26 -- Navigating The Regulatory Space To Biosimilar Approval
810            </a>
811        </li>
812        <li class="title-link-container">
813            <a href="/doc/your-collaborator-mab-productivity-and-robustness-0006" title="09.17.26 -- Your Collaborator: mAb Productivity And Robustness" class="title-link">
814                09.17.26 -- Your Collaborator: mAb Productivity And Robustness
815            </a>
816        </li>
817        <li class="title-link-container">
818            <a href="/doc/a-much-improved-approach-for-managing-safety-risks-0001" title="09.17.26 -- A Much-Improved Approach For Managing Safety Risks" class="title-link">
819                09.17.26 -- A Much-Improved Approach For Managing Safety Risks
820            </a>
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824                09.16.26 -- Smarter Ways To Reduce Risk, Downtime, And Lifecycle Surprises 
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855        online: window["__currentOnline__"],
856        captchaTokenUrl: '/recaptcha',
857        recaptchaKey: '6LcrGKAqAAAAAIQ61nMY1RsFKOhCpnJ4t6q8_UU0'
858      });
859   }
860})
861</script>
861
862    </main>
863</div>
864
865
866<footer class="border-top vert-footer d-print-none">
867    <div class="container">
868        <div class="row">
869                <div class="col-sm">
870
871                        <h5 class="text-dark text-primary">Partner With Us</h5>
872                        <ul class="list-unstyled">
873                                <li>
874                                    <a href="/doc/media-kit-request-0002" >Request More Information</a>
875                                </li>
876                                <li>
877                                    <a href="/premier-advertisers" >Our Partners</a>
878                                </li>
879                        </ul>
880                        <h5 class="text-dark text-primary">Subscribe</h5>
881                        <ul class="list-unstyled">
882                                <li>
883                                    <a href="https://www.biosimilardevelopment.com/user/new" >Newsletter</a>
884                                </li>
885                        </ul>
886                </div>
887                <div class="col-sm">
888
889                        <h5 class="text-dark text-primary">Life Science Connect</h5>
890                        <ul class="list-unstyled">
891                                <li>
892                                    <a href="https://www.advancingrna.com/" >Advancing RNA</a>
893                                </li>
894                                <li>
895                                    <a href="https://www.bioprocessonline.com/" _target=&quot;_blank&quot;>Bioprocess Online</a>
896                                </li>
897                                <li>
898                                    <a href="https://www.cellandgene.com/" _target=&quot;_blank&quot;>Cell &amp; Gene</a>
899                                </li>
900                                <li>
901                                    <a href="https://www.clinicalleader.com/" _target=&quot;_blank&quot;>Clinical Leader</a>
902                                </li>
903                                <li>
904                                    <a href="https://www.clinicalsupplyleader.com/" >Clinical Supply Leader</a>
905                                </li>
906                                <li>
907                                    <a href="https://www.clinicaltechleader.com/" >Clinical Tech Leader</a>
908                                </li>
909                                <li>
910                                    <a href="https://www.drugdiscoveryonline.com/" _target=&quot;_blank&quot;>Drug Discovery</a>
911                                </li>
912                                <li>
913                                    <a href="https://www.drugdeliveryleader.com/" >Drug Delivery Leader</a>
914                                </li>
915                                <li>
916                                    <a href="https://www.laboratorynetwork.com/" _target=&quot;_blank&quot;>Laboratory Network</a>
917                                </li>
918                                <li>
919                                    <a href="https://www.lifescienceleader.com/" _target=&quot;_blank&quot;>Life Science Leader Magazine</a>
920                                </li>
921                                <li>
922                                    <a href="https://www.meddeviceonline.com/" _target=&quot;_blank&quot;>Med Device Online</a>
923                                </li>
924                                <li>
925                                    <a href="https://www.outsourcedpharma.com/" _target=&quot;_blank&quot;>Outsourced Pharma</a>
926                                </li>
927                                <li>
928                                    <a href="https://www.pharmaceuticalonline.com/" _target=&quot;_blank&quot;>Pharmaceutical Online</a>
929                                </li>
930                        </ul>
931                </div>
932                <div class="col-sm">
933
934                        <h5 class="text-dark text-primary">Editorial</h5>
935                        <ul class="list-unstyled">
936                                <li>
937                                    <a href="https://www.biosimilardevelopment.com/hub/bucket/biosimilar-newsletter-archive" >Archived Newsletters</a>
938                                </li>
939                                <li>
940                                    <a href="/doc/article-reprints-0003" >Article Reprints</a>
941                                </li>
942                                <li>
943                                    <a href="/doc/guest-expert-article-guidelines-0001" >Editorial Submission Guidelines</a>
944                                </li>
945                                <li>
946                                    <a href="/resource/expert-network" >The Expert Network</a>
947                                </li>
948                        </ul>
949                        <h5 class="text-dark text-primary">Events</h5>
950                        <ul class="list-unstyled">
951                                <li>
952                                    <a href="https://www.cmoleadershipawards.com" _target=&quot;_blank&quot;>CMO Leadership Awards</a>
953                                </li>
954                                <li>
955                                    <a href="https://pharmasource.global/events/live-events/cdmo-live-americas/?utm_source=lsc_bios&amp;utm_medium=website&amp;utm_campaign=footer_link" _target=&quot;_blank&quot;>CDMO Live Americas</a>
956                                </li>
957                                <li>
958                                    <a href="https://pharmasource.global/events/cdmolive/?utm_source=lsc_bios&amp;utm_medium=website&amp;utm_campaign=footer_link" _target=&quot;_blank&quot;>CDMO Live Europe</a>
959                                </li>
960                                <li>
961                                    <a href="https://pharmasource.global/external-manufacturing-leaders/?utm_source=lsc_bios&amp;utm_medium=website&amp;utm_campaign=footer_link" _target=&quot;_blank&quot;>External Manufacturing Leaders</a>
962                                </li>
963                        </ul>
964                </div>
965                <div class="col-sm">
966
967                        <h5 class="text-dark text-primary">Learn More</h5>
968                        <ul class="list-unstyled">
969                                <li>
970                                    <a href="https://www.biosimilardevelopment.com/solution/about-biosimilar-development" >About Us</a>
971                                </li>
972                                <li>
973                                    <a href="https://www.biosimilardevelopment.com/solution/contact-biosimilar-development" >Contact Us</a>
974                                </li>
975                                <li>
976                                    <a href="https://lifescienceconnect.com/careers/" _target=&quot;_blank&quot;>Work For Us</a>
977                                </li>
978                        </ul>
979                </div>
980        </div>
981    </div>
982        <div class="container pb-3">
983            <div class="d-print-none row no-gutters justify-content-center">
984                <div class="d-none d-md-block col-auto">
985                    
986
987<!-- Adds PubAds Section -->
988<script>
989    googletag.cmd.push(function () {
990        googletag
991        .defineSlot('/52748101/biosimilardevelopment/bios-leaderboard', [728,90], 'Ad_91b93e82-8da1-4cc7-8d97-5d335712a75f')
992        .addService(googletag.pubads());
993        googletag.pubads().enableLazyLoad({
994            fetchMarginPercent: 50,
995            renderMarginPercent: 0,
996            mobileScaling: 2.0,
997        });
998        googletag.pubads().enableSingleRequest();
999        googletag.enableServices();
1000    });
1001</script>
1001
1002<div id="Ad_91b93e82-8da1-4cc7-8d97-5d335712a75f" class="ad ">
1003        
1003<script>
1004        document.addEventListener("DOMContentLoaded", function () { 
1005        vertLib.site.Common.setupObserverIntersection("#Ad_91b93e82-8da1-4cc7-8d97-5d335712a75f", () => {
1006                googletag.cmd.push(function () {
1007                    googletag.display("Ad_91b93e82-8da1-4cc7-8d97-5d335712a75f");
1008                    });
1009                });   
1010        });        
1011        </script>
1011
1012    
1013</div>
1014
1015
1016                </div>
1017                <div class="d-none d-md-block col-auto pl-2">
1018                    
1019
1020<!-- Adds PubAds Section -->
1021<script>
1022    googletag.cmd.push(function () {
1023        googletag
1024        .defineSlot('/52748101/biosimilardevelopment/bios-earpiece', [230,90], 'Ad_af149aeb-db0f-41ba-a36b-03d272c80390')
1025        .addService(googletag.pubads());
1026        googletag.pubads().enableLazyLoad({
1027            fetchMarginPercent: 50,
1028            renderMarginPercent: 0,
1029            mobileScaling: 2.0,
1030        });
1031        googletag.pubads().enableSingleRequest();
1032        googletag.enableServices();
1033    });
1034</script>
1034
1035<div id="Ad_af149aeb-db0f-41ba-a36b-03d272c80390" class="ad ">
1036        
1036<script>
1037        document.addEventListener("DOMContentLoaded", function () { 
1038        vertLib.site.Common.setupObserverIntersection("#Ad_af149aeb-db0f-41ba-a36b-03d272c80390", () => {
1039                googletag.cmd.push(function () {
1040                    googletag.display("Ad_af149aeb-db0f-41ba-a36b-03d272c80390");
1041                    });
1042                });   
1043        });        
1044        </script>
1044
1045    
1046</div>
1047
1048
1049                </div>
1050            </div>
1051        </div>
1052
1053    <div class="container small pb-3 text-center">
1054        <a href="/static/copyright">Copyright</a>
1055        &copy; 1996-2026 <a href="https://www.vertmarkets.com">VertMarkets, Inc.</a>
1056        All Rights Reserved.
1057        <a href="/static/legal">Terms of Use</a>.
1058        <a href="/static/privacy">Privacy Statement</a>.
1059        <a href="/user-request">Subscriber Request Form</a>.
1060        <a href="/user-request?privacyType=ccpa">Don't sell my information</a>
1061    </div>
1062</footer>
1063
1064
1065
1066<!-- Google Tag Manager -->
1067<script type="text/javascript">
1068    let score = '';
1069    let gtmEvents = [];
1070    
1071    function loadRecaptcha () {
1072        if (vertLib && typeof vertLib.site.Common.getRecaptchaToken === 'function') {
1073            // when load and library is loaded then execute           
1074                vertLib.site.Common.setupGTM(dataLayer);
1075            vertLib.site.Common.getRecaptchaToken('ga').then(function (token) {
1076                return $.post('/recaptcha', { token: token });
1077            }).then(function (response) {
1078                score = response.score.toString();
1079                    gtmEvents = [{"$type":"Vert.Sites.Web.Models.Analytics.Events.GtmUserDataEvent, Vert.Sites.Web","event":"page_view","event_category":"","event_action":"","event_source":"server_side","portal":"BIOS"}] || [];
1080                    vertLib.site.Common.logGTMEvents(gtmEvents, score, dataLayer);
1081            });
1082        }
1083    }
1084</script>
1084
1085
1086<script async='async' src='https://www.googletagservices.com/tag/js/gpt.js'></script>
1086
1087
1088<!-- End Google Tag Manager -->
1089    
1090 
1090<script type="text/javascript">
1091    window["munchkinUrl"] = 'https://app-ab30.marketo.com';
1092    window["munchkinFormId"] ='1067'
1093    window["munchkinInstanceId"] = '075-NVC-086';
1094</script>
1094
1095
1096<script>
1097    window.addEventListener('load', initMunchkin);
1098    
1099    function initMunchkin() {
1100        if (vertLib && typeof vertLib.site.Common.associateMunchkin === 'function') {
1101            vertLib.site.Common.associateMunchkin({ Email: window['__USER_EMAIL__'], UserId: window['__USER_ID__'] });                
1102        }
1103    }
1104</script>
1104
1105
1106<div id="userSubscriptionFormModal" class="modal">
1107    <div class="modal-dialog vm-modal">
1108        <div class="modal-content">
1109            <div class="modal-header">
1110                <img src="https://vertassets.blob.core.windows.net/sites/logos/bios.png" alt="Biosimilar Development" class="mt-3" />
1111                <button type="button" class="close" data-dismiss="modal" aria-hidden="true">&times;</button>
1112            </div>
1113            <div class="modal-body">
1114                <div id="userSubscriptionContainer">
1115    <div id="areaOfFocus" class="mt-3 mx-4 mb-4"></div>
1116    <div id="login" class="mt-3 mx-4 mb-4"></div>
1117</div>
1118
1119<script id="areaOfFocusTemplate" type="text/x-template">
1120    {{@if (it.message)}}
1121        <div class="alert alert-success d-flex flex-row p-2 m-0">
1122            <i class="fa fa-info mr-2 mt-1"></i>
1123            <div>{{it.message | safe}}</div>
1124        </div>
1125    {{/if}}
1126    <form method="post" action="/user-subscription/update" id="areaOfFocusForm" class="vm-form-alt">
1127        {{@if (it.showUserInfoFields)}}
1128            <div>
1129                <div class="pt-3">Please tell us more about you so that we can customize our newsletters to your specific interests:</div>
1130                <div class="row">
1131                    <div class="form-group col-md-6">
1132                        <label for="JobTitle">Job Title</label>
1133                        <input type="text" class="form-control form-control-sm" id="JobTitle" name="JobTitle" value="{{ it.jobTitle }}" />
1134                    </div>
1135                    <div class="form-group col-md-6">
1136                        <label for="Company">Company</label>
1137                        <input type="text" class="form-control form-control-sm" id="Company" name="Company" value="{{ it.company }}" />
1138                    </div>
1139                </div>
1140            </div>
1141        {{/if}}
1142        {{@if (it.subscriptions.length)}}
1143            <div class="vm-checkbox-container primary">
1144                 <div class="form-check-inline p-2 input-container form-check">
1145                    {{@if (it.subscriptions[0].isSelected)}}
1146                        <input type="checkbox" name="subscriptions" checked="checked" value="{{it.subscriptions[0].id}}" class="form-check-input"/> <label class="form-check-label">{{it.subscriptions[0].text}}</label>
1147                    {{#else}}
1148                        <input type="checkbox" name="subscriptions" value="{{it.subscriptions[0].id}}" class="form-check-input"/> <label class="form-check-label">{{it.subscriptions[0].text}}</label>
1149                    {{/if}}
1150                </div>
1151            </div>
1152        {{/if}}
1153        {{@if (it.personas.length)}}
1154            <div class="vm-checkbox-container">                
1155                <div class="p-4 input-container">
1156                    <div class="topics-blurb">What topics interest you?  (Check all that apply.)</div>
1157                    {{@each(it.personas) => pers, index}}                        
1158                        {{@if (index%2 === 0)}}
1159                            <div class="row pl-3 vm-checkbox-container">
1160                        {{/if}}
1161                         <div class="col-md-6 text-capitalize form-check">
1162                            {{@if (pers.isSelected)}}
1163                                <input type="checkbox" name="personas" checked="checked" value="{{pers.id}}" class="form-check-input"/> <label class="form-check-label">{{pers.text}}</label>
1164                            {{#else}}
1165                                <input type="checkbox" name="personas" value="{{pers.id}}" class="form-check-input"/> <label class="form-check-label">{{pers.text}}</label>
1166                            {{/if}}
1167                        </div>
1168                        {{@if (index%2 !== 0 && index > 0)}}
1169                            </div>
1170                        {{/if}}                       
1171                    {{/each}}
1172                    {{@if (it.personas.length%2 === 0)}}
1173                        </div>
1174                    {{/if}}
1175                </div>
1176            </div>
1177        {{#elif (it.subscriptions.length)}}
1178            <div class="pt-3">You may also be interested in these industry newsletters:</div>
1179            <div class="p-4 input-container">
1180                {{@each(it.subscriptions) => sub, index}}
1181                    {{@if (index > 0)}}
1182                        {{@if (index%2 !== 0)}}
1183                            <div class="row pl-3 vm-checkbox-container">
1184                        {{/if}}
1185                        <div class="col-md-6 text-capitalize form-check">
1186                            {{@if (sub.isSelected)}}
1187                                <input type="checkbox" name="subscriptions" checked="checked" value="{{sub.id}}" class="form-check-input"/> <label class="form-check-label">{{sub.text}}</label>
1188                            {{#else}}
1189                                <input type="checkbox" name="subscriptions" value="{{sub.id}}" class="form-check-input"/> <label class="form-check-label">{{sub.text}}</label>
1190                            {{/if}}
1191                        </div>                        
1192                        {{@if (index%2 === 0)}}
1193                            </div>                        
1194                        {{/if}}
1195                    {{/if}}
1196                {{/each}}
1197                {{@if (it.subscriptions.length%2 === 0)}}
1198                    </div>
1199                {{/if}}
1200                <button id="selectAll" type="button" class="btn btn-link pl-0 pt-2">Select All</button>
1201            </div>            
1202        {{/if}}
1203        <div class="row justify-content-end">
1204            <div class="col-12">
1205                <button type="submit" class="btn vm-alt-button mt-4">
1206                    <span class="vm-button-text">Finish</span>
1207                </button>
1208            </div>
1209        </div>
1210        <input type="hidden" name="OnlineId" id="OnlineId" value="{{it.onlineId}}" />
1211    </form>
1212</script>
1212
1213
1214<script id="loginTemplate" type="text/x-template">
1215    {{@if (it.message)}}
1216        {{@if (it.hasError)}}
1217            <div class="alert alert-danger d-flex flex-row p-2 m-0">
1218        {{ #else }}
1219            <div class="alert alert-warning d-flex flex-row p-2 m-0">
1220        {{/if}}
1221            <i class="fa fa-info mr-2 mt-1"></i>
1222            <div>{{it.message | safe}}</div>
1223        </div>
1224    {{/if}}
1225    <form method="post" action="/user-subscription/login" id="loginForm" class="vm-form-alt">
1226        <div class="row">
1227            <div class="form-group col">
1228                <label for="Email">Email</label>
1229                <input type="text" class="form-control form-control" id="Email" name="Email" maxlength="100" value="{{it.email}}" />
1230            </div>
1231        </div>
1232        <div class="row">
1233            <div class="form-group col">
1234                <label for="Password">Password</label>
1235                <input type="password" class="form-control form-control" id="Password" name="Password" />
1236            </div>
1237        </div>
1238        <div class="row">
1239            <div class="form-group col">
1240                <small>
1241                    <a href="/password/forgotpassword">Forgot your password?</a>
1242                </small>
1243            </div>
1244        </div>
1245        
1246        <div class="vm-oauth-providers">
1247            <span class="small mb-4">... or you can:</span>
1248            <a class="btn btn-lg rounded-circle" role="button" href="/user-oauth/login?oAuthType=Google&source=user-sub">
1249                <i class="fa fa-google" aria-hidden="true"></i>
1250            </a>
1251            <a class="btn btn-lg rounded-circle" role="button" href="/user-oauth/login?oAuthType=Facebook&source=user-sub">
1252                <i class="fa fa-facebook" aria-hidden="true"></i>
1253            </a>
1254            <a class="btn btn-lg rounded-circle" role="button" href="/user-oauth/login?oAuthType=LinkedIn&source=user-sub">
1255                <i class="fa fa-linkedin" aria-hidden="true"></i>
1256            </a>
1257        </div>
1258
1259        <div class="row justify-content-end">
1260            <div class="col-12">
1261                <button type="submit" class="btn vm-alt-button mt-4">
1262                    <span class="vm-button-text">Sign In</span>
1263                </button>
1264            </div>
1265        </div>        
1266        
1267        <input type="hidden" name="JobTitle" id="JobTitle" value="{{it.jobTitle}}" />
1268        <input type="hidden" name="Company" id="Company" value="{{it.company}}" />
1269        <input type="hidden" name="OnlineId" id="OnlineId" value="{{it.onlineId}}" />
1270        <input type="hidden" name="Privacy" id="OnlineId" value="{{it.privacy}}" />
1271    </form>
1272</script>
1272
1273
1274<script>
1275    window.userSubSettings = undefined;
1276</script>
1276
1277            </div>
1278        </div>
1279    </div>
1280</div>
1281
1282
1283    
1284
1285
1286
1287<script id="modalTemplate" type="text/x-template">
1288    <div class="modal fade" id="{{ it.id }}" role="dialog" tabindex="-1" data-keyboard="false" data-backdrop="{{ (it.backdrop || 'true') }}">
1289        <div class="modal-dialog vm-modal">
1290            <div class="modal-content">
1291                {{ @if(it.title) }}
1292                <div class="modal-header no-gutters justify-content-between">
1293                    <div class="col">
1294                        <h2>{{ it.title | safe }}</h2>
1295                    </div>
1296                    <div class="col-auto">
1297                        <div class="vm-ajax-loader"><span></span></div>
1298                        <button type="button" class="close" data-dismiss="modal" aria-hidden="true">&times;</button>
1299                    </div>
1300                </div>
1301                {{ /if }}
1302                <div class="modal-body">{{ it.body | safe }}</div>
1303                {{ @if (it.hideFooter !== true) }}
1304                <div class="modal-footer">
1305                    <div class="row justify-content-end">
1306                        <div class="col-12">
1307                            <button type="button" data-dismiss="modal" class="btn vm-button">Close</button>
1308                        </div>
1309                    </div>
1310                </div>
1311                {{ /if }}
1312            </div>
1313        </div>
1314    </div>
1315</script>
1315
1316
1317</body>
1318</html>

Line numbers count LF bytes from the start of the resource, as the search results do. Vendor segments are library code the classifier recognised; they are stored but not indexed. Bytes are shown as Latin1 characters, one per byte.