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US Supreme Court rebuffs Sandoz’s Enbrel biosimilar patent case

Amgen will retain market exclusivity on blockbuster arthritis drug until 2029

The US supreme court has decided not to review a patent case brought forward by Novartis’ generics division Sandoz for its Enbrel biosimilar Erelzi.

Erelzi references Amgen’s blockbuster arthritis drug Enbrel (etanercept) – Sandoz had been hoping to launch the biosimilar as a ‘more affordable’ treatment option for US patients.

However, the US Supreme Court has denied a petition to review an earlier Federal Circuit decision – announced in July 2020 – regarding Sandoz’s Enbrel patent case.

This decision also ruled against Sandoz, with the Federal Circuit instead choosing to uphold two of Amgen’s patents on the drug. Previously, Sandoz had argued that “the patents asserted by Amgen are not valid, and that it should not be able to use them to extend the drug’s exclusivity”.

Frustratingly for Sandoz, its Enbrel biosimilar was the first to receive approval from the US Food and Drug Administration (FDA) in 2016.

Due to the ongoing patent issues, Sandoz has been unable to launch Erelzi since then, and will be unable to do so until 2029, when Amgen’s patents on the drug expire.

“We are disappointed the Supreme Court decided not to review our case. Today’s decision means Erelzi, a more affordable biosimilar, will not be available to US patients with autoimmune and inflammatory diseases until 2029; nonetheless we remain committed to providing important treatment options for patients affected by these diseases,” said Keren Haruvi, president of Sandoz US and head of North America.

Enbrel, which yielded approximately $5bn in sales in 2020, was first approved in 1998 and can be used for the treatment of a number of autoimmune conditions, including rheumatoid arthritis, psoriatic arthritis and plaque psoriasis.

In a statement, Amgen said: “We are pleased that the Supreme Court has declined to hear Sandoz’s appeal in the Enbrel patents case, finally bringing this dispute to an end. As the trial court and appeals court decisions make plain, upon both the facts and the law, these patents are valid and protect Enbrel until their expiration.”

Article by
Lucy Parsons

18th May 2021

From: Regulatory



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