Accelerated approval for dostarlimab-gxly (Jemperli) pairs a single-arm phase 2 dataset with an FDA-authorized biomarker test and confirmatory requirements.
News|Podcasts|April 2, 2026
Analytics that Matter: How LC and MALS Drive Biosimilar Success
Author(s)Waters
The October 2025 FDA draft guidance for biosimilars marks a major shift toward greater reliance on analytical data. Most notably, it signals a move to reduce or even eliminate comparative efficacy studies when robust analytics can provide equivalent insight, detecting subtle differences that clinical studies often miss. Biosimilar development will continue to require comprehensive analytical packages, with emphasis on orthogonal techniques. This session features Colette Quinn from Waters Corporation, who discusses how analytics support biosimilar development and help meet the FDA’s “totality-of-evidence” expectations.
Learn more about:
- The FDA’s 2025 biosimilar guidance and its emphasis on analytical data over comparative efficacy studies
- How LC and MALS provide orthogonal, fit-for-purpose methods to assess critical quality attributes and reduce uncertainty
- How integrated workflows with Empower software improve reproducibility, efficiency, and compliance in biosimilar development
Related to this article
BMS's Dr Nathan Pennell outlines how biomarker testing barriers and trial diversity affect patient access to targeted oncology drugs.
In the phase 3 SHINE-2 trial, half of pediatric patients who responded to mirikizumab induction were in clinical remission at week 52. Lilly plans to file for a pediatric UC label expansion.
Guselkumab (Tremfya) sustained perianal fistula healing through 1 year in Crohn disease, with remission climbing to 35% in one FUZION dosing arm.
Roche will take ex-China development of Hansoh’s two preclinical ADCs and multiple programs against Roche-proposed targets once Hansoh completes global phase 1a trials. The deal includes $400 million upfront and more than $15 billion in potential milestones.
Cemiplimab's proposed EU regimen could cut Libtayo infusion visits from every 3 weeks to every 6 weeks, trimming infusion time by up to half.
Opus Genetics reports sustained vision gains with gene therapy, the FDA approves Roche’s Enspryng for at-home treatment of thyroid eye disease, and Estuary Biotherapeutics launches with $103 million to develop gene therapies for polycystic kidney disease.
When large pharmaceutical companies deprioritize drug candidates, smaller developers may license or acquire them, but due diligence, deal structure, and trial planning determine whether a program can move forward.
Trending on BioPharm International
1
FDA Approves Roche’s Enspryng as First At-Home Subcutaneous Treatment for Thyroid Eye Disease
2
Estuary Biotherapeutics Launches With $103 Million for ADPKD Gene Therapy
3
BioPharm Brief: Gene Therapy Progress, FDA Approval, and $103M Funding
4
Roche, Hansoh Sign Second ADC Pact Covering Preclinical and Roche-Selected Targets
5