Federal Circuit Rules Upholds Lower Court Ruling in Biosimilar Erelzi Case

Sandoz, a Novartis division, announced the US Court of Appeals for the Federal District has ruled against Sandoz in patent litigation concerning the Sandoz biosimilar Erelzi® (etanercept-szzs) for reference medicine Enbrel® (etanercept).

This decision upholds a prior ruling from the New Jersey District Court, which declared the Amgen patents valid. Sandoz is evaluating its options, which may include an appeal to the US Supreme Court.

“Sandoz will continue its efforts to make Erelzi available to US patients with autoimmune and inflammatory diseases,” said Carol Lynch, President of Sandoz US 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 is the first company to receive approval from the US Food and Drug Administration (FDA) for a biosimilar etanercept. Erelzi has been approved in the US for more than three years, since August 2016, however Sandoz has been unable to launch this medicine in the US due to the ongoing patent litigation with Amgen.

“Biosimilars can make tremendous contributions to the sustainability of US healthcare and enhance patient access to biologic medicines, which are often life-changing treatment options for patients with chronic illness,” said Colin C. Edgerton, MD, 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.”