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Wednesday, July 1, 2020

Sandoz May Appeal to US Supreme Court in Biosimilar Erelzi Case

Novartis AG’s Sandoz division is evaluating its options, including a potential appeal to the U.S. Supreme Court, after a U.S. court ruled against the company in a patent litigation related to the Sandoz biosimilar Erelzi.
The Swiss drugmaker said Wednesday that the U.S. Court of Appeals for the Federal District upheld a previous ruling declaring Amgen Inc.’s patents valid.
“Sandoz will continue its efforts to make Erelzi available to U.S. patients with autoimmune and inflammatory diseases,” said Carol Lynch, president of Sandoz U.S. and head of North America. “Our company respects valid intellectual property, however Sandoz continues to believe the patents asserted by Amgen are not valid, and that it should not be able to use them to extend the drug’s exclusivity.”
Sandoz’s biosimilar Erelzi was approved by the U.S. Food and Drug Administration in 2016 but the company hasn’t been able to launch it in the U.S. due to the patent litigation with Amgen.

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