Amgen, Novartis biosimilars news
The U.S. District Court for the Northern District of California denied Amgen’s motions seeking to prevent Novartis’ Sandoz Inc. generics unit from marketing Zarxio filgrastim-sndz, a biosimilar of Amgen’s Neupogen filgrastim methionyl human G-CSF. The court ruled that Sandoz did not violate the Biologics Price Competition and Innovation Act of 2009 (BPCIA) when it refused to provide its BLA to Amgen because the law contemplates an alternative scenario. The BPCIA offers a temporary safe harbor from litigation if a biosimilar developer provides a BLA to a reference product’s sponsor, but specifies that the reference product sponsor “may bring an action” against the biosimilar maker immediately if the biosimilar developer does not. The court determined that failure to provide the BLA alone does not constitute basis for injunctive relief, restitution or damages.
The court also dismissed Amgen’s claim that Sandoz violated the BPCIA when it gave Amgen its 180-day notice of intent to market Zarxio in advance of FDA approving the drug. The court said Congress likely did not intend for the BPCIA to add an extra six months of market exclusivity onto the 12-year period sponsors of reference products already receive. ...