A joint venture between Biogen and South Korean giant Samsung won Europe's first approval for a lower-cost version of Amgen and Pfizer's blockbuster Enbrel, planning to launch its injection in the coming weeks.
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.
Amgen, at work on a biosimilar of AbbVie's best-selling treatment, got an unfavorable decision from U.S. regulators that could delay the launch of its take on Humira.
All eyes may be on rising drug costs, but that doesn't mean pharma companies are backing away from price hikes. In recent days, analysts have spotlighted hundreds of increases, more than 100 of them at Pfizer alone, that took effect January 1.
The Canadian unit of U.S.-based Amgen has launched legal action against Samsung Bioepis, saying two of its patents for the autoimmune treatment Enbrel (entanercept) were violated by Samsung's biosimilar Brenzys.
On Dec. 31, the struggling York, PA, micro-cap inked a nonexclusive deal with Amgen to supply the Big Biotech with already existing wearable injector devices "for use with certain large volume drug products," as well as its 1-mL wearable injector "for use with certain small volume drug products."
In 2015, the FDA by its own account approved 45 new drugs, the largest one-year tally since 1996, which wrapped up with a record 53 regulatory OKs. Now, here's the full list of new drugs approved by the FDA in 2015, in chronological order.
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.
The wait for outcomes data on Amgen's PCSK9 drug Repatha just got shorter. As CardioBrief reports, top-line results of a study called Fourier will be available in the second half of 2016.
Amgen, months removed from a landmark FDA approval in oncology, is buying further into viruses that can hunt and kill cancer within the body.