Last Thursday, the FDA issued the first set of long-awaited draft guidelines for the regulatory approval of follow-on biologic drug products, or "biosimilars," under the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"). While the pharmaceutical industry has eagerly awaited the FDA's announcement of its views on the regulatory requirements for biosimilar approval, the agency has declined, for now, to provide the type of detailed description many have been seeking. Instead, the draft guidelines set forth general principles to be applied during the approval process and made clear that the regulatory requirements that biosimilar applicants will be required to meet will be highly product dependent. As a result, while these guidelines provide useful insights into the FDA's views on the approval of biosimilar applications, the full scope of the challenges associated with obtaining regulatory approval for biosimilars remains uncertain.
The FDA draft guidelines are composed of three "Guidance for Industry" documents:
• "Quality Consideration in Demonstrating Biosimilarity to a Reference Protein Product" ("Quality Guidelines")
• "Scientific Consideration in Demonstrating Biosimilarity to a Reference Product" ("Scientific Guidelines")
• "Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and
Innovation Act of 2009" ("Biosimilars Q&A").
Although not legally binding, these guidelines provide a description of the FDA's most current thinking about the biosimilar approval process. The Quality Guidelines set forth the analytical requirements for biosimilar approval, while Scientific Guidelines describe the clinical trial requirements for biosimilar approval. The Biosimilars Q&A provides general principles the FDA intends to apply to the approval of biosimilar products. Public comments on the draft guidelines will be accepted for 60 days.
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