publication date: Jun. 16, 2017

Sandoz prevails over Amgen in Supreme Court case on marketing biosimilars

By Claire Dietz

Resolving a three-year-long court fight, the U.S. Supreme Court June 12 ruled that Sandoz can commence marketing of its biosimilar white blood cell growth factor immediately after getting FDA approval.

Amgen Inc., the sponsor of the reference agent, was seeking to make Sandoz wait for six-months after approval.

Sandoz is a division of the Novartis Group.

The unanimous ruling ends what insiders call the “patent dance,” a Kabuki-like process whereby two drug companies take delicate steps around each other while sorting out patent rights involved in bringing a biosimilar product to market.

“We appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward,” Carol Lynch, global head of biopharmaceuticals at Sandoz, said in a statement. “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.”

Amgen did not respond to questions from The Cancer Letter by deadline.

The case began in 2014, when Sandoz filed an application with FDA to market a biosimilar filgrastim called Zarxio, with Amgen’s Neupogen, as the reference product.

Amgen holds patents on the methods of manufacturing and using filgrastim, the generic name for the drug. Here is where the dance gets complicated: the process to discuss patents can be lengthy, taking up to eight months to be exact. This, combined with waiting for FDA approval, can result in a loss of over a year’s potential profits for the company. So Sandoz decided to bypass all that by filing litigation that ended up lasting over three years.

When FDA … Continue reading Sandoz prevails over Amgen in Supreme Court case on marketing biosimilars

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