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Not So Different: Should Biosimilar Variations Be Concerning?
Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert, explains the relevance of differences between biosimilars and reference biologics.
Although the European Union has been in the biosimilars game longer than the United States, both are considered leaders in biosimilar use. Generics were the first copycat drugs, however, there are lessons to be learned from this experience. But biologics, which are made from living organisms, are not as simple to copy as generics are. There will be minute differences between biosimilars and originator biologics, and there will even be small differences between different batches of the same originator biologic. We now have reliable tests for determining whether these differences are clinically significant or not. But what does our experience so far with biosimilars and originators tell us about these differences?
We sat down with Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert who was part of the team that developed and presented evidence to the FDA for the first successfully approved US biosimilar, Zarxio, a filgrastim product developed by Sandoz. Paul helped explain these issues.
To hear more from Paul on biosimilar issues, click here or here.
To read about Paul’s insight on the current issues in the Indian biosimilar market, click here.
Treatment Persistence, Safety After Switching to Infliximab Biosimilars in Canadians With IBD
October 5th 2024A retrospective study of a mandatory nonmedical switch in Canada found no significant differences in rates of treatment persistence, loss of response, or adverse events in patients with inflammatory bowel disease (IBD) on maintenance therapy 1 year post-switch.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Eye on Pharma: EC Approved Ustekinumab; Zymfentra Expansion; Biosimilar Policy Briefing
September 26th 2024The European Commission (EC) approved Celltrion's ustekinumab biosimilar for chronic inflammatory diseases, Celltrion expanded access to Zymfentra (subcutaneous infliximab-dyyb) through partnerships with Cigna and Express Scripts, and the Association for Accessible Medicines held a policy briefing addressing barriers to biosimilar adoption.
