Biosimilar Guidance Comments Reveal Small Window Of Agreement On Foreign Data
In comments on FDA’s three biosimilar draft guidances, PhRMA and BIO seek a more limited role in biosimilar approval decisions for clinical data involving foreign reference products than does GPhA, but all the trade associations believe that the foreign product needs to be made by the same company in the same facility as the U.S.-licensed reference product.
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Biosimilar Vs. Therapeutic Protein Immunogenicity: Industry Makes Distinction
Responding to FDA’s draft guidance on immunogenicity assessment for therapeutic protein products, BIO says the agency should consider different principles when deciding procedures to detect immune response to biosimilars; Momenta wants the agency to draw a distinction between immunogenicity and safety testing.
FDA’s Plan for Biosimilars: Science to Trump Dissonance
FDA aims to cut through dissonance over biosimilars by focusing on the analytical science.
Bydureon Approval Provides Lesson In Clinical Data Requirements For Biosimilars
Changes in the manufacturing site and production scale for exenatide extended-release complicated FDA’s review of Bydureon, Amylin’s follow-on agent to Byetta, and late-rising questions about the drug’s QT effects made FDA revisit its earlier conclusion that the investigational and commercial formulations were comparable. The agency’s decision to require additional clinical data in a second “complete response” letter suggests biosimilar sponsors will face a similarly high clinical hurdle.