FDA Gathering Biosimilar Stakeholders for Input on Implementing the New Legislation

FDA will be holding a two-day public hearing to obtain input on specific issues and challenges associated with the implementation of the new biosimilars legislation.  The meeting is set for November 2-3 at FDA’s White Oak campus in Silver Spring, MD.

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was introduced in Congress last fall and signed into law in March.  The Act establishes an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to, or “interchangeable” with, an FDA-licensed biological product.

The agency will take the information it obtains from the public hearing into account in its implementation of the BPCI Act and in the development of related guidances and rulemaking.

At the hearing, the agency is seeking input on the following questions in particular:

● What factors should be considered to determine biosimilarity or interchangeability?

● What factors unique to biosimilars should be considered in designing pharmacovigilance programs for them?

● Should animal or clinical data from a non-US-licensed comparator product be considered?

● What scientific factors should be considered when developing a regulatory definition for “protein”?

● What types of guidance should be a priority for the agency at this time?

● What factors should be considered in deciding how marketing exclusivity applies to BLAs transferred between companies?

This hearing represents an important step in the journey toward putting in place the regulatory framework needed for approving biosimilar molecules in the US.  An approval system has been in place in the EU since 2006 and the EMA’s portfolio of biosimilar products continues to grow (IPQ “In the News”August 21).

FDA has not been discussing biosimilar issues at public forums while it digests the implications of the recently-passed legislation (IPQ “In the News” June 22).

[More on the challenging questions the agency will need to address in implementing the legislation is provided for subscribers here.  For subscription information click here.]

Another recent related IPQ story:
Understanding Biosimilar/Biobetter Approval Pathways and Differences Key to Success, Merck Exec Says