Novartis abandons efforts for US approval of biosimilar rituximab

(Reuters) – Novartis International AG announced on Friday that its Sandoz division was abandoning its efforts to obtain US regulatory approval for a biosimilar for rituximab, a drug used to treat certain cancers and rheumatoid arthritis.

The decision came after the Food and Drug Administration (FDA) asked for additional information in support of the company's application for the drug, which has already been approved by the EU, Switzerland, Japan and the United States. Australia, the company said in a statement.

"We are disappointed to have to make this decision and defend the safety, efficiency and quality of our medicines," said Stefan Hendriks, Global Head of Biopharmaceuticals at Sandoz.

Rituximab is a biosimilar drug that refers to a drug from Roche Holding AG marketed as Rituxan in the United States, Japan, and Canada, as well as under the name MabThera elsewhere. According to badysts, Rituxan, a monoclonal antibody used in non-Hodgkin's lymphoma and rheumatoid arthritis, sold more than $ 4 billion in the United States in 2016.

A biosimilar is a biological drug that is virtually identical to the reference product.

In October, an FDA panel recommended the approval of Truxima, another biosimilar for rituximab, from Celltrion Inc in South Korea and Teva Pharmaceutical Industries Ltd. in Israel. Approval is expected by the end of November or the month of December.

Sandoz said he is engaged in a robust biosimilar portfolio. It has seven biosimilars approved worldwide, including three in the United States.

Sandoz has received a full response letter from the US FDA – a communication that tells a company that its application can not be approved in its current form – for biosimilar rituximab on May 2.