- On July 24, Sandoz became the first company to file for biosimilar approval in the U.S. under the FDA's 351(k) pathway.
- Sandoz, a subsidiary of Novartis, filed for approval of Zarzio (filgrastim), a biosimilar version of Amgen's Neupogen.
- Sandoz filed a lawsuit with the U.S. Court of Appeals of the Federal Cicuit to preemptively make sure that its biosimilar does not violate any patent laws, with the goal of staving off any patent-infringement lawsuits from Amgen later. However, the court has now rejected this suit, calling it premature.
Sandoz is at the forefront of the issue of defining the biosimilar approval pathway in America. By attempting to identify potential patent conflicts earlier in the process rather than later, the company could buy time and smooth the process toward post-approval marketing.
But it all comes down to how the Biologics Price Competition and Innovation Act (BPCIA) is interpreted. The main issue is whether Sandoz should be required to provide Amgen with a complete copy of its biosimilar application. It is unclear just how this will play out with future biosimilar applicants, since the court's refusal to hear the case leaves some questions unanswered, as the WSJ points out. But this is an important part of setting the stage for large-scale biosimilar development, approval, and availability.