Biosimilar Clinical Trials Face Enrollment Challenges
Education for investigators and patients about the biosimilar development process, including what’s already known about a product being studied, could help trial recruitment, FDA, industry and patient reps say.
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Pfizer commits to “late November” launch for its biosimilar version of infliximab, partnered with Celltrion, which will be the second biosimilar to reach the US market. Remicade innovator Janssen considers it an “at risk” launch and will continue patent litigation, as well as commercial tactics to protect its market.
FDA panelists' confusion over biosimilarity and overwhelming approval endorsements following glowing agency reviews suggest the meetings may not be having much impact on FDA deliberations; however, agency sees an opportunity to learn from what its external experts don't understand about biosimilars.
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.