Biosimilars

AbbVie digs in for a long war as Amgen bags first OK for a Humira biosimilar

The FDA provided its stamp of approval on Amgen’s biosimilar of AbbVie’s anti-inflammatory megablockbuster Humira. But don’t look for any cheaper copies of the drug anytime soon. AbbVie plans to fight to the last lawyer keeping the competitor off the market, claiming it has patents in place to bar this and other rivals in the works for another six years.

Janet Woodcock

Janet Woodcock

AbbVie has plenty to gain and much to lose when it comes to Humira and the biosimilar market. The company earned about $14 billion off the one franchise last year, and the numbers keep headed north. In the second quarter, its flagship drug brought in $4.15 billion. Humira provides roughly two thirds of its revenue and AbbVie has been fighting for more time — lots more time — to develop new drugs to take its place.

Amgen, meanwhile, will be pushing to get their copycat — named Amjevita — on the market sometime next year, hoping that once the main patent lapses in December they can fight their way out front. Meanwhile, Merck/Samsung Bioepis, Novartis and Shire (Baxalta)/Momenta also have knockoffs in the clinic, looking to line up for a share of the market as well.

The slate of new approvals on biosimilars, with one unexplained rejection for Novartis, has helped illuminate the FDA’s attitudes toward biosimilars. Clean data on one central indication appears good enough to win approvals for a full slate of indications. And the agency appears ready to move quick and fast to green light these drugs, even if patent battles are likely to take much longer to play out.

Amgen, for example, has been playing defense on the biosimilars front as well as offense. The company has been fighting a delaying action against Novartis’ approved rival Zarxio, a copy of neupogen.

“This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.


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