A federal appeals court has ruled that Novartis can begin selling its lower-cost copy of an Amgen drug in September, rejecting a bid to further delay the launch of the knock-off biotech medication.
Novartis received federal approval in March to sell its cheaper copy of Amgen's Neupogen, which is used to boost blood cells in cancer patients. It was the first time the Food and Drug Administration had approved a lower-cost copy of a biotech drug.
But the launch of Novartis' Zarxio has been delayed by litigation brought by Amgen.
On Tuesday, the U.S. Court of Appeals for the Federal Circuit rejected Amgen's claims of unfair competition but also said Novartis would have to wait until Sept. 2 before selling its drug.
The delayed launch stems from a provision of the law governing approval of biosimilars, the industry term for the quasi-generic biotech drugs. The court ruling handed down Tuesday states that companies marketing new biosimilars must give 180 days advance notice to the original drugmaker after receiving FDA approval. Novartis had argued that the 180 days' notice could be given prior to FDA approval.
The court ruling means biotech makers like Amgen can expect six additional months of exclusive marketing for their drugs even after a biosimilar is approved.
In Europe, Novartis has sold its version of Neupogen, called Zarzio there, since 2009. The drugmaker also markets two other biosimilar drugs in about 60 countries.
Other blockbuster biotech drugs expected to face biosimilar competition in the U.S. include anti-inflammatory drugs Remicade and Humira and cancer drugs Herceptin and Avastin.
While generics have been on the market as cheaper alternatives to brand-name chemical medicines for decades, biologic alternatives are not identical to their brand-name analogs because they are derived from living organisms.
Prior to 2010 then the Biologics Price Competition and Innovation Act of 2009 was enacted there was no regulatory pathway that allowed for biosimilars to be marketed in the U.S.
Some estimates project the market for biosimilars in the U.S. will grow to $60 billion by 2020 as the patent protections on a number of biologic medications are set to expire over the next several years.
