According to a SCOTUSblog Opinion analysis on June 12, “The Supreme Court reverses another Federal Circuit patent case… Sandoz emerged as the clear victor in the case, winning the right to bring “biosimilar” versions of complex biologic drugs to market sooner and also gaining a small but potentially important procedural right for future litigations.”
FiercePharma reports that “In landmark Amgen v. Sandoz ruling, biosim makers can give notice before FDA nod…Biosim makers scored a big win Monday as the Supreme Court ruled with Sandoz in a much-watched legal dispute with Amgen. The landmark decision, set to leave a distinct mark on the budding field, allows biosim makers to give marketing notice before FDA approval, meaning their products can launch faster.”
In related news, 2017 is setting up to be a landmark year for both biosimilars and complex generics, as FDA reports GDUFA II, set to take effect in October “would establish a pre-ANDA program. It would clarify regulatory expectations for prospective applicants early in product development and help applicants develop more complete submissions, thus promoting a more efficient and effective review process.” Here’s FDA testimony before the US Senate describing the Pre-ANDA program (scroll halfway down and look under the heading “Reauthorization”).
Meanwhile, In the Federal Register of January 18, 2017 (82 FR 5579), FDA published a notice with a 60-day comment period as it sought to finalize the Draft Guidance “Considerations in Demonstrating Interchangeability With a Reference Product.” However, on March 15 (82 FR 13819), in response to several requests, FDA extended the comment period until May 19, 2017. The comment period has now closed after over 50 comments were received.
According to FDALawBlog, “Most commenters addressed the same points: the distinction between interchangeability and biosimilar, switching studies, use of foreign reference products, and the necessity of demonstrating interchangeability in all indications or uses and in all presentations. Questions are raised throughout the comments about what interchangeability actually means: is it a higher standard or just an additional data requirement? Is it therapeutic equivalence? And everyone is nervous about whether FDA will use labeling or nonproprietary naming or something totally new to indicate that a biosimilar is interchangeable. The commenters were also torn on the use of foreign reference products – mostly breaking down into a cost compared to safety argument.”