Court: Biosimilar Patent Dance Is Optional; Approval Needed For Market Notice

A federal appeals court ruled Tuesday (July 21) that biosimilars makers don't have to go through the so-called patent dance with the reference product sponsor, but the court said 180-day notices of commercial marketing are mandatory when sponsors don't disclose manufacturing information and that 180 days may only begin after products receive FDA approval. Sandoz gave Amgen notice upon approval, after giving them an early notice in July 2014, so the ruling means the first biosimilar would be available on...