The launch of Erelzi, Novartis’s FDA-approved etanercept (Enbrel) biosimilar, will be delayed at least another year as a patent fight with Amgen continues in US federal court, according to Richard Francis, global head of Novartis’s Sandoz generic division. Amgen is arguing in US federal court that its biologic Enbrel has patent protection until 2029. The lawsuit won’t reach a conclusion until 2018, Francis stated, adding that while the legal situation is frustrating he believes the company is “carving the landscape out as we go.”
Erelzi is the first biosimilar of etanercept to be approved by the FDA. It was approved on August 30, 2016, with an indication for the same indications as the reference drug Enbrel: rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis. Amgen sued Novartis over patent issues before the FDA had even approved Erelzi.
Novartis and Amgen are also engaged in a separate legal case concerning Novartis’s Zarxio, a biosimilar of Amgen’s Neupogen (filgrastim), which was approved by the FDA in September 2015. This dispute revolves around whether biosimilar sponsors have to provide 180 days’ notice to the reference product’s company after FDA approval to begin marketing the biosimilar. Novartis is arguing that by making the biosimilar’s sponsor wait until FDA approval to notify the originator company of a launch, the court was creating “an exclusivity windfall” for the originator company that Congress did not intend in the Biologics Price Competition and Innovation Act. Novartis believes the biosimilar sponsor should be able to provide notice earlier in development and be able to launch the biosimilar soon after FDA approval. The Supreme Court recently agreed to consider that case.