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.
The Growing Impact of Biosimilars in IBD Care
April 23rd 2025Biosimilars are proving to be a game-changing solution in the fight against inflammatory bowel disease (IBD), offering a cost-effective alternative to biologics with similar efficacy and safety, while innovative drug delivery systems promise to further enhance treatment outcomes and accessibility for millions worldwide.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.