Sandoz Decides Not To Pursue US Biosimilar Rituximab

(RTTNews) - Novartis AG (NVS) said that its Sandoz division has decided not to pursue its submission for biosimilar rituximab in the US at this time to treat certain cancer and rheumatoid arthritis.

The company specified that the decision comes after the U.S. Food and Drug Administration sought additional information to complement the submission.

Sandoz said it remains committed to enabling early and expanded patient access and creating savings for healthcare systems through a robust biosimilar portfolio.

"We are disappointed to have to make this decision and stand behind the safety, efficacy and quality of our medicine," said Stefan Hendriks, global head of biopharmaceuticals at Sandoz.

The drug already approved in the EU, Switzerland, Japan and Australia, the company said in a statement.

On May 2, Sandoz said that the US Food and Drug Administration has issued a complete response letter regarding the Biologics Licensing Application for its proposed biosimilar rituximab.

Sandoz has seven approved biosimilars worldwide, three of which are approved in the US, and is currently awaiting marketing authorization in the EU for pegfilgrastim, following a CHMP positive opinion in September 2018.