FDA Release of Biosimilar Guidance Documents Opens Up New Chapter in Dialogue with Industry

FDA has released the much-anticipated draft guidance documents on the scientific and quality considerations for registering biosimilar products through the abbreviated licensure pathway established by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) – opening up a new chapter in the dialogue with industry on the future shape of biosimilar regulation in the US.

Accompanying the two draft guidances is a substantive 15-page Q&A document on BPCI Act implementation. The Q&A addresses key questions that may arise during the development of biosimilars and/or that the agency has already fielded from prospective sponsors.

The comment period for the three draft documents is 60 days from their upcoming publication in the Federal Register. A fact sheet highlighting the three documents and a short Q&A on their issuance were also released.

The release was announced by CDER Director Janet Woodcock at a House Energy and Commerce Committee Health Subcommittee hearing on generic drug and biosimilar user fees and drug shortages held on February 9 (see IPQ February 12 and 13 companion stories). The attention being placed by Congress on biosimilars, user fees, and drug shortages reflects their prominence in the current regulatory dialogue for generic drugs.

The draft guidances follow on the heels of the release by FDA of its 2012-2017 performance goals for authorizing biosimilar products as also called for under the BPCI Act (IPQ “In the News” December 28, 2011).

The guidance on biosimilars was carefully thought through by FDA in terms of: ● the agency’s health protection responsibilities ● alignment with the intent of the legislation, and ● assuring that the directions would be reasonable, consistent and viable for industry in helping it move forward in biosimilar development.

The draft documents reflect the public input at an FDA hearing on the BPCI Act held in late 2010. The comments were generally in favor of making overarching guidances describing the general principles for biosimilar product development a first priority.

The document release effectively ends the moratorium the agency had put in place on publicly discussing the complexities of interpreting and implementing the legislation while its regulatory policies were being developed (IPQ “In the News” June 22, 2010).

[An analysis of the key issues addressed in the new FDA biosimilar guidances and accompanying Q&A are provided for subscribers here. Nonsubscribers can purchase the story for $195 by contacting Karen Bertani (Jonathan@ipq.org). For subscription/license information, click here.]

See related stories:

FDA’s Proposed Biosimilar User Fee Structure Explained to Congress by CDER’s Woodcock

More Manufacturing Discontinuance Notices Help FDA Ease Drug Shortages, Agency Reports at House Hearing

FDA Releases Biosimilar Authorization Performance Goals for Comment as Efforts to Implement the New Act Continue

Generic Drug User Fee Act Nearing Finalization