Sandoz reviewing options after Federal Circuit upholds lower court ruling in biosimilar Erelzi case

Sandoz, a Novartis division and a global leader in biosimilars, recently announced that the U.S. Court of Appeals for the Federal District had ruled against the comapny in patent litigation concerning Erelzi (etanercept-szzs), its biosimilar of Enbrel (etanercept).

The decision upholds a prior ruling from the New Jersey District Court, which declared the Amgen patents valid. In light of the ruling, Sandoz is evaluating its options, which may include an appeal to the U.S. Supreme Court.

“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 was the first company to receive approval from the FDA for biosimilar etanercept. Erelzi has been approved in the United States for nearly four years, since August 2016, however Sandoz has been unable to launch this medicine in the United States due to the ongoing patent litigation with Amgen.

“Biosimilars can make tremendous contributions to the sustainability of U.S. healthcare and enhance patient access to biologic medicines, which are often life-changing treatment options for patients with chronic illness,” said Colin Edgerton, a rheumatologist and executive chairman of the American Rheumatology Network. “Data and real-world experience affirm there are no changes in safety and efficacy when patients switch between a biosimilar and a reference medicine.”