Sandoz to appeal court ruling on Enbrel biosimilar

BY Sandra Levy

The U.S. District Court of New Jersey on Friday ruled against Sandoz in patent litigation concerning Erelzi (etanercept-szzs), the company’s biosimilar of Amgen’s Enbrel. The ruling upheld the validity of two Amgen patents relating to Enbrel.

“We are pleased with today’s decision recognizing the validity of these patents. Protecting intellectual property is critical to incentivize innovation and the large investments in research and development that are required to bring new medicines to patients and fully develop their therapeutic potential for patients,” Amgen chairman and CEO Robert Bradway said.

Sandoze said that it will be appealing the ruling to the U.S. Court of Appeals for the Federal Circuit, and the parties have agreed to an expedited appeal.

“Sandoz respectfully disagrees with the court’s ruling, which prevents us from launching an additional treatment option for patients with autoimmune and inflammatory diseases,” said Carol Lynch, president of Sandoz U.S. and head of North America. “Valid intellectual property should be respected, however, we continue to consider the patents in this case to be invalid. Amgen asserted two patents that it obtained from Roche, in what we believe is an attempt to extend its U.S. compound patent protection for etanercept to 2029. We will appeal this decision, and look forward to presenting our case to the Federal Circuit and bringing Erelzi to U.S. patients as soon as possible.”

Sandoz is the first biosimilar company to receive FDA approval for biosimilar etanercept. Erelzi has been approved for nearly three years, however, Sandoz has been unable to launch the medicine due to the ongoing patent litigation from Amgen.


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