Biosimilars

Amgen loses its bid to delay biosimilars as SCOTUS hands Novartis a victory

Amgen took their argument that its biosimilar rivals should be forced to delay their 180-day marketing notices until after the FDA had made up its mind on the marketing application all the way to the Supreme Court — and lost.

In a unanimous ruling handed down mid-day Monday, the Supreme Court decided the key question by determining that the law never imposed a two-tier timing system for these notices. Therefore “the applicant may provide notice either before or after receiving FDA approval.”

That marked a clear win for Sandoz, the big Novartis generics unit which is fielding a full slate of these copycat biologics. The group is launching a knockoff of Amgen’s Neupogen, and in the process helped speed the arrival of a fresh wave of biosimilars hitting US market shores.

It’s a setback for Amgen, but before the Supreme Court ruled against it, the pharma giant was able to celebrate a different kind of win. The FDA rejected Coherus’ application for a biosimilar of Neulasta, which effectively delays any rival there from this year until 2018, at the earliest.

Lawyers for Sandoz had argued that Congress clearly never intended to provide bonus time to the 12 years of marketing exclusivity provided by the law. And the company celebrated the ruling Monday afternoon.

“The Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments. We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward,” said Carol Lynch, Global Head of Biopharmaceuticals, Sandoz, in a statement. “As the global leader in biosimilars, it is our responsibility to help eliminate barriers so patients can access more affordable medicine. The results of this Supreme Court case reinforce that the work we are doing every day has meaning to the patients and customers we are here to help.


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RAPS Regulatory Convergence 2017