First Biosimilar Receives Legal Clearance for US Market

Zarxio (filgrastim-sndz), manufactured by Sandoz as a biosimilar to Amgen's Neupogen, has finally received marketing approval from a federal appeals court.

Sandoz has finally received permission to commercialize its biosimilar filgrastim-sndz (Zarxio), 6 months following regulatory approval. While rejecting Amgen's claims of unfair competition, a federal appeals court has mandated that Novartis wait till September to bring the product to market. The court ruling handed down Tuesday states that companies marketing new biosimilars must give 180 days advance notice to the original drugmaker, in this case Amgen, after receiving FDA approval. This gives the original manufacturer of the biological 6 additional months of exclusive marketing rights.

The progress in this case has been closely watched by payers, patients, and drug manufacturers because biosimilars are forecast to save an estimated $44 billion in US healthcare costs over the next decade.