On June 12, 2017, the Supreme Court issued a unanimous ruling in Sandoz Inc. v. Amgen Inc. The case interprets two provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and is expected to significantly impact the approval and patent litigation processes for biosimilar applications. First, the BPCIA requires a biosimilar applicant
The US Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final guidances on biosimilar clinical pharmacology and biologics non-proprietary naming, as well as a draft guidance on biosimilar interchangeability. In parallel, litigation that should clarify the BPCIA patent resolution process, including timing of the
FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for moving protein products currently approved under the drug statute (section 505 of the Food, Drug and Cosmetic Act) to the biologics system (section 351 of the Public Health Service Act).
As biosimilar applications begin rolling in, FDA has issued two of its 2014 “promised” guidances, addressing important issues of how the agency is implementing the BPCIA: (1) what information FDA will consider to determine “first licensure” for a biologic licensed under 351(a), which is essentially a decision on eligibility for the 12-year exclusivity period provided to new biologics; and (2) regulatory expectations for clinical pharmacology in support of a biosimilar application.