The first U.S. biosimilar, Zarxio, should be on the market by September, after an appeals court ruled in its favour.
In a move that has surprised some, Zarxio, the first FDA-approved biosimilar looks set for a September market launch after a U.S. appeals court ruled its maker had not violated any information disclosure requirements.
The 2-to-1 vote in the U.S. Court of Appeals for the Federal Circuit rejected the claim by Amgen, the patent holder of originator drug, Neupogen, that Zarxio’s maker Sandoz had violated Biologic Price Competition and Innovation Act information disclosure provisions by not supplying Zarxio’s license application to them. But the court interpreted these provisions as optional, not mandatory, as Amgen had argued.
