Biosimilars in the United States: Current Status and Future Implications

Biosimilars in the United States: Current Status and Future Implications

Disclosures: Haruvi reports employment relationship with Sandoz.
May 17, 2021
2 min read
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Supreme Court declines to hear Sandoz's appeal for Enbrel biosimilar, upholds Amgen patent

Disclosures: Haruvi reports employment relationship with Sandoz.
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The U.S. Supreme Court has denied a petition from Novartis’ Sandoz to review an earlier U.S. appeals court ruling in favor of Amgen’s etanercept against etanercept-szzs, effectively blocking the biosimilar from entering the U.S. market.

In July 2020, the U.S. Court of Appeals for the Federal Circuit ruled in a 2-1 decision that the Sandoz biosimilar Erelzi (etanercept-szzs) infringed on two Enbrel (etanercept) patents for active ingredient — U.S. Patent No. 8,063,182 — and manufacturing process — U.S. Patent No. 8,163,522.

The U.S. Supreme Court has denied a petition from Sandoz that requested the court review an earlier appeals court ruling that has blocked its etanercept biosimilar from entering the U.S. market on the grounds of patent infringement. Source: Adobe Stock

Although these two Enbrel patents will not expire until 2029, Sandoz has previously asserted 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.”

In response to the appeals court ruling, Sandoz filed a petition for certiorari requesting review of the judgment, arguing that “patentees may not obtain two patents on the same invention.” However, the Supreme Court opted not to hear the case at this time.

“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,” Amgen said in a statement. “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.”

Sandoz became the first company to receive FDA approval for an etanercept biosimilar nearly 5 years ago, in August 2016. However, the drug has yet to launch in the U.S. due to the ongoing patent litigation with Amgen.

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

Keren Haruvi

Although Sandoz previously acknowledged that its biosimilar infringed on Amgen’s patents, the manufacturer countered that these two patents should not have been granted as the concepts were already contained in prior patents.

However, in a previous U.S. District Court ruling in 2019, Judge Claire C. Cecchi determined that Sandoz had “failed to show by clear and convincing evidence that the Patents-in-Suit are invalid” and ruled that the manufacturer had failed to meet the burden of proof to justify the patent infringements of its biosimilar.