Riddle Me This, Biosimilar

After much back and forth and legal wrangling, the first US biosimilar – Sandoz’s Zarxio (a biosimilar of Amgen’s Neupogen) – is set to launch in early September. A ruling from the US Court of Appeals for the Federal Circuit stated that biosimilar manufacturers must wait 180 days to launch a product after receiving FDA approval – March 6, 2015 for Zarxio. Will there be additional chapters in the saga? Ask Amgen… The case, which began in October 2014, has been closely watched; after all, many thought it would set a precedent for future biosimilar launches. The Federal Circuit admitted that it has been a difficult case, demanding that it  “unravel the riddle, solve the mystery, and comprehend the enigma” of the US Biologics Price Competition and Innovation Act (BPCIA) (1).

Interpretation of the BPCIA lies at the heart of the argument. For example, the BPCIA states that manufacturers must give 180 days’ notice of their intent to launch a biosimilar, but there are differing opinions as to exactly what that means. In March, the US District Court for North California dismissed Amgen’s claim that the notice could only be given after FDA approval (rather than before), since this would effectively turn the notice into an “automatic 180-day bar against marketing”. But in a two-to-one decision in July, the Federal Circuit agreed with Amgen that notice should be given after approval. Not every aspect of the case went in Amgen’s favor. Another point of contention between Amgen and Sandoz was the sharing of information regarding the biosimilar application (the so-called “patent dance”). Amgen argued that the BPCIA required Sandoz to provide information to Amgen about the application so that the company could check for patent infringement, but the Federal Circuit agreed with Sandoz that this was optional.

The judiciary process was certainly not clear cut; three judges were involved in the case, two of whom dissented in part. Indeed, the final ruling stated that decisions had to be made from a “series of imperfect choices”.

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