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.
Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.