FDA issues 3 draft guidances on biosimilars

February 14, 2012

FDA has issued 3 draft guidances for the development of biosimilar versions of approved biologic products, which will help flesh out the abbreviated approval pathway created by the Patient Protection and Affordable Care Act signed into law in 2010.

FDA has issued 3 draft guidances for the development of biosimilar versions of approved biologic products, which will help flesh out the abbreviated approval pathway created by the Patient Protection and Affordable Care Act (PPACA) signed into law in 2010.

PPACA amended the Public Health Service Act under section 351(k) to create a pathway to approve biologics that are shown to be high similar, or biosimilar, or interchangeable with biologics already licensed by FDA.

The 351(k) pathway allows FDA to approve biologics that are highly similar to an existing biologic and that show no clinically meaningful differences in terms of safety, purity, and potency compared to the reference biologic. Biosimilars may be approved regardless of any minor differences in clinically inactive components compared to the reference biologic.

The FDA published 3 separate guidance documents:

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product lays out a risk-based “totality-of-the-evidence” approach to demonstrate that a proposed therapeutic protein is biosimilar to a reference product for the purpose of submitting a 351(k) application.

Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product discusses the analytical factors that should be taken into account.

Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 answers common questions that may arise in the early stages of the biosimilar development process.

But don’t expect to see biosimilars any time soon. The draft guidances are only a first step. FDA said it wants public comment on the proposed guidances, but has not yet told the public how, where, or when to submit comments.

FDA is playing catch-up with the European Medicines Agency, which has already approved more than a dozen biosimilars for sale in the European Union. Bernstein Research estimates that about $54 billion worth of biologics will be off patent and open for biosimilar competition by 2020. The company predicts annual biosimilar sales of up to $8 billion approximately 8 years from now.