The FDA today issued three draft guidance documents on biosimilar development. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product describes how the FDA will determine biosimilarity through a stepwise approach to evaluating evidence. Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product discusses analytical factors that manufacturers should consider when trying to assess biosimilarity between a reference product and a proposed biosimilar. And Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 covers questions from potential biosimilar manufacturers and the FDA’s responses to them.
The FDA is seeking comments on all three documents.
Among some of the points covered in the Q&A is that a biosimilar applicant may use data on a non-U.S. licensed comparator product to help support certain biosimilar claims. In addition, a proposed biosimilar can have a different formulation and route of administration than the reference product, as well as be licensed for fewer presentations and conditions of use. It also can have a different device or container system than the reference product has, but there are additional standards applied in this situation.
Is there anything in the documents that is particularly controversial? What parts do you think will garner the most comments, and why? Is there anything that is likely to change in the final document?
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