Novartis abandons effort for U.S. approval of biosimilar rituximab

The Sandoz division of Novartis International AG says it will no longer try to gain U.S. regulatory approval for a biosimilar of rituximab, which is used to treat certain cancers and rheumatoid arthritis.

The Sandoz division of Novartis International AG says it will no longer try to gain U.S. regulatory approval for a biosimilar of rituximab, which is used to treat certain cancers and rheumatoid arthritis. The decision came after FDA requested additional information to support the company's application for the drug, which is approved already in the European Union, Switzerland, Japan, and Australia. "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. An FDA committee recently recommended approval of Truxima, another biosimilar for rituximab, from South Korea's Celltrion and Israel's Teva Pharmaceuticals, and approval is expected later this year.