- In what many observers and market players hope will clarify the biosimilar approval route, the U.S. Supreme Court has agreed to hear two related lawsuits over certain Obamacare provisions governing biosimilars.
- The dispute centers on Novartis (NVS -0.5%) Sandoz unit's marketing application for its biosimilar to Amgen's (AMGN +0.5%) Neupogen (filgrastim), approved in the U.S. in September 2015. Sandoz is marketing the product under the brand name Zarxio.
- Amgen sued Sandoz in an attempt to block Zarxio's approval but failed. The ruling by the U.S. Court of Appeals, which set the approval date, was a bit muddled. Amgen and Sandoz both filed suit against portions of the decision.
- The Appeals Court said Sandoz was not required to give Amgen information about its biosimilar application, including a description of the manufacturing process. It added that Amgen could file a patent infringement suit instead (it did so, the trial is set to start in December).
- Amgen's position is that the law says Sandoz "shall" give the information and the failure to do so warrants an injunction barring Zarxio sales. Sandoz sued over the requirement that it had to give Amgen 180 days' notice after FDA approval before it could start selling the product.
- The specific date of the hearing has not been set.