By Henriette Kuehne, Kristof Vandekerckhove, Carol Kirchhoff
On December 12, 2018, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act (Revision 2). FDA issued the draft guidance to facilitate the development of proposed biosimilars and proposed interchangeable biosimilars and to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance document revises the draft guidance document entitled Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009, issued May 13, 2015, to provide new and revised questions and answers.
The BPCI Act amended the Public Health Service Act (PHS Act) and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act (42 USC 262(k)) for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product (see sections 7001 through 7003 of the Patient Protection and Affordable Care Act [Pub. L. 111-148]). FDA believes that guidance for industry that provides answers to commonly asked questions regarding FDA's interpretation of the BPCI Act will enhance transparency and facilitate the development and approval of biosimilar and interchangeable products. FDA intends to update this guidance to include additional questions and answers as appropriate.
The AAPS Biosimilar Development, Strategy, and Implementation Community leadership developed comments that were submitted to FDA on February 8, 2019. Noteworthy comments included requests for clarification regarding how to:
- define biosimilar product “strength” in terms of label claim, net quantity of content, and potentially different overfill requirements between biosimilar and reference products (especially in the context of lyophilized products);
- implement the new recommendation to include a biosimilarity assessment in comparability studies supporting postapproval changes (whether to include historical or fresh reference product, execute historical or current methods, etc.); and
- obtain FDA letters or other assistance with sourcing of reference product if access is deliberately restricted by the reference product manufacturer (e.g., through a REMS program).
View the AAPS Biosimilar Community’s submitted comments on the Federal eRulemaking Portal.