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by Amanda Conschafter, blog editor

Though newly finalized guidance from the FDA has provided some clarity on biosimilarity, crucial questions about the regulation of biosimilars remain unanswered. As a Capitol Hill panel of physicians and advocates explained on May 19, naming conventions and labeling for biosimilars still require clarification. These issues have serious implications for patient safety, panelists explained, as do procedures for biosimilar substitution.

Hosted by the Alliance for Patient Access, the congressional briefing explored FDA activities related to the biosimilar drug approval process – in particular, naming, indication extrapolation and biosimilar labeling. Panelist Raymond Cross, MD, cited the need for prescribers to have clear, accurate information about biosimilars to give them confidence in the new drugs. Panelist and attorney Steven Grossman suggested steps that the FDA should consider to ensure patient safety and widespread adoption of biosimilars.

[READ: Informed Prescribing: Physicians Need Complete and Specific Prescribing Information for Biosimilar Medications


The panel also included patient advocates from the Global Healthy Living Foundation and the Arthritis Foundation. Both articulated the challenges that patients face with drug substitution – and how those challenges are magnified if naming and labeling don’t provide clear data or substitutions aren’t disclosed in a timely manner.

[WATCH: How to Safely, Effectively Substitute Biological Medicines]

To offer a member of Congress’ perspective, House Energy and Commerce Committee Vice Chair Marsha Blackburn (TN-7) addressed drug development and the introduction of biosimilar medicines. Congressional pressure on the FDA to provide clear biosimilar guidance has grown in recent weeks; the Health, Education, Labor & Pensions Committee publicly pressured FDAfor final guidance in a April 30 letter. The agency’s decisions about unique naming and labeling have not yet been disclosed.

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