Beyond Biosimilarity: Draft Guidance for Demonstrating Biologic Interchangeability

The primary focus of the FDA, industry, and counsel preparing for the advent of follow-on biologics in the United States has been the legal and regulatory framework governing the approval of such products as biosimilars under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). However, the BPCIA further provides that the FDA may determine that a biologic product is also interchangeable with (and thus, under Federal law, freely substitutable for) its reference product. As stakeholders anticipate the potential for “generic biologics,” the FDA has released a draft guidance outlining considerations for applicants seeking to demonstrate interchangeability. This draft guidance sheds some light on the burdens sponsors of proposed interchangeable biological products (“interchangeables”) will (and will not) face along the path to interchangeable licensure.