On Monday, Amgen said the FDA had accepted its application for its biosimilar of AbbVie's Humira, so-called ABP 501--but earlier this month, the U.S. Patent and Trademark Office shut down its challenge to Humira's patents.
Amgen and Pfizer's Enbrel officially has a biosimilar rival in Europe. And if the rollout goes anything like the recent EU launch of Remicade copy Remsima, the blockbuster brand will be in trouble.
Amgen has hit a potential snag in its quest to bring a biosimilar of AbbVie cash cow Humira to market. Thursday, the U.S. Patent and Trademark Office declined to review a pair of formulation patents on the arthritis drug, determining that "based on the petition and the accompanying evidence … Amgen has not shown a reasonable likelihood of prevailing on any of its challenges," Reuters reports.
With one biosim already on the U.S. market, and more poised for a 2016 liftoff, next year will give drugmakers and payers a taste of the biosim contest to come.
Partners Baxalta and Momenta Pharmaceuticals, among the many contenders looking to challenge the world's top-selling drug, posted positive data for their take on AbbVie's Humira with hopes of launching a competitor in 2018.
Samsung Group's pharmaceutical division appears to be betting the farm on a plan to be the go-to guy when it comes to actually making biosimilar drugs, eschewing contract research and becoming the leading contract manufacturer of them.
The globe's largest clinical research organization is looking to India as a source for the next waves of biosimilars as $55 billion worth of biotech drugs face patent expirations.
Remsima, a biosimilar of Johnson & Johnson's Remicade from Pfizer's Hospira and partner Celltrion, is tearing it up in Europe. But don't expect things to play out the same way in the U.S., a Bernstein analyst says.
Apotex is working on a biosimilar of Amgen's Neulasta, but if and when it wins FDA approval, it'll have to wait awhile before launching, a court ruled on Wednesday.
The launch of the first biosimilar in the U.S., Sandoz's Zarxio, has stimulated tremendous market opportunities, with sales predictions for biosimilars pointing to $25 billion by 2020, according to a 2014 Thomson Reuters report.