- The FDA has denied Amgen's Citizen's Petition arguing that Novartis division Sandoz violated a key federal law.
- Amgen contended that Sandoz was required to provide a complete copy of its biosimilar marketing application 20 days after submission to the FDA, as well as provide it to Amgen.
- The FDA has disagreed with Amgen's interpretation of the Biologics Price Competition and Innovation Act.
This is the second time that the FDA has rejected a request from Amgen that could delay introduction of biosimilar Neupogen (filgrastim). The first time, Amgen claimed that Sandoz was required to provide a six-month notice of its sales plans ahead of marketing filgrastim.
With respect to the latest effort, the concern for Sandoz is that Amgen could use the information in the submission paperwork to assess whether there is a patent violation. It all comes down to how the Biologic Price and Competition Act is being interpreted in light of continuous efforts on the part of Amgen to delay introduction of biosimilar Neupogen into the marketplace.
The fact is there are billions of dollars riding on the outcome. The Rand Corporation forecasts that biosimilars will save an estimated $44 billion in healthcare costs over the next decade in the US alone.