On June 12, 2017, the Supreme Court issued a unanimous opinion in Sandoz v. Amgen, interpreting key provisions of the Biologics Price Competition and Innovation Act (BPCIA) in favor of biosimilar manufacturers (applicants). In particular, the Court held that (1) a federal injunction is not available to compel biosimilar applicants to disclose application and manufacturing information as contemplated by the BPCIA, and (2) biosimilar applicants may provide statutory 180-day notice of commercial marketing after or before receiving FDA approval.
The BPCIA “patent dance”
The BPCIA was approved by Congress in 2010 for the purpose of creating an abbreviated approval pathway for biosimilars, or follow-on biologics. In contrast to conventional chemically synthesized drugs, biologics are isolated from natural sources such as animals or microorganisms and may include such diverse products as vaccines, recombinant proteins or somatic cells. Biosimilar manufacturers may take advantage of the BPCIA’s abbreviated approval pathway to piggyback on the safety, purity and potency showings of a previously licensed reference product. In exchange, the BPCIA allows for up to 12 years of regulatory exclusivity for the reference product after the date the product was first licensed, regardless of whether there is patent protection. Continue Reading