On Friday, Amgen submitted its Opening and Response Brief at the Supreme Court in the matter of Sandoz v. Amgen, Nos. 15-1039, 15-1195. The brief addressed two major questions with respect to the BPCIA: when an applicant can provide 180-day notice of biosimilar marketing and …
Well, that was quick! Only two weeks after filing, the U.S. District Court of Delaware dismissed Genentech’s Complaint under the Biologics Price Competition and Innovation Act (“BPCIA”) against Amgen. As we explained here, Genentech sued Amgen for failure to comply with the patent dance provisions …
2017 is already shaping up to be a big year in court for Amgen and the Biologics Price Competition and Innovation Act (“BPCIA”). As regular readers know, Amgen’s challenge to Sandoz’s refusal to participate in the patent dance after filing of an aBLA relying on …
After months of promises and postponements, FDA has finally published its long-awaited draft guidance on biological product interchangeability, Considerations in Demonstrating Interchangeability With a Reference Product, under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). While FDA had originally promised the guidance in …
Last January, when FDA issued the Agency’s Calendar Year 2016 Guidance Agenda, we were pretty stoked to seek guidance was planned on various ANDA and Hatch-Waxman issues, including “Three-Year Exclusivity Determinations for Drug Products;” “Submission of ANDAs for Certain Highly Purified Synthetic Peptide Drug Products;” …
