Posted by Michael Wonder on 18 Mar 2017
Guide to recent biosimilar activity by FDA and in the Supreme Court
16 March 2017 - The US 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issuing final guidances on biosimilar clinical pharmacology and biologics non-proprietary naming, as well as a draft guidance on biosimilar interchangeability.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 biosimilar applicant’s notice of commercial marketing is proceeding through the Supreme Court.
Guidance for Industry: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (December 2016): With this guidance, FDA finalises the previous draft guidance of the same title. The final guidance largely tracks the previous draft. Of note, the final guidance removes categories of “similarity” in favour of describing certainty about similarity derived from analytical data on a development-phase continuum. This change is consistent with the statutory requirement that a biosimilar must be “highly similar” to the reference product.
