FDA Finalizes Guidance Documents On Biosimilars


Six years after legislation was adopted creating a new pathway for the approval of biological products that are biosimilar to existing FDA-approved biologics, the Food and Drug Administration (FDA) continues to issue guidance to clarify its interpretation of the law.

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated licensure pathway within the Public Health Service Act (PHS Act) for biological products that are biosimilar to or interchangeable with an FDA-licensed biological product. The BPCI Act essentially created a pathway similar to an Abbreviated New Drug Application, which is used to approve generic drugs, that applies to biologics.

In a series of three final guidance documents issued in late April 2015, the FDA seeks to explain its interpretation of assorted issues concerning the BPCI Act. Those issues include scientific considerations of establishing biosimilarity, quality considerations demonstrating biosimilarity of a therapeutic protein product, and other issues concerning biosimilarity, and requirements for submitting a biologic license application (BLA). Draft versions of these guidance documents were issued in February 2012. The FDA has been seeking input on the BPCI Act since shortly after its enactment; in November 2010, the FDA held a public hearing and established a public docket to solicit input on issues related to implementing the BPCI Act.

Interested persons may submit comments regarding these guidance documents either at http://www.regulations.gov or to the Division of Dockets Management.

Scientific Considerations

The guidance document titled Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, Guidance for Industry intends to assist sponsors in demonstrating biosimilarity between a therapeutic protein product (i.e., the proposed product) and a reference product through the abbreviated licensure pathway created under Section 351(k) of the PHS Act. As an initial matter, the guidance points out that sponsors should be aware of the complexities of protein products and take this into consideration when designing a development program to demonstrate biosimilarity. The guidance then addresses an approach to demonstrating biosimilarity and how the FDA will evaluate that demonstration.

The FDA recommends a stepwise approach to obtain the data and information necessary to support the demonstration of biosimilarity. Using the stepwise approach will allow a...

To continue reading