FDA approves first biosimilar of Roche's anti-cancer drug Rituxan

(Reuters) – Truxima, of Celltrion Inc., became Wednesday the first biosimilar of the $ 7 billion annual Rituxan anticancer drug from Roche Holding AG to be approved in the United States for the treatment of lymphoma non-Hodgkin's.

The approval of the US Food and Drug Administration is part of the agency's plan to encourage the development of cheaper biosimilars in the face of rising prescription drug prices.

To date, the FDA has approved 14 other biosimilars, including copies of the top-selling drugs, such as Abbie Inc's Humira and Amgen's Neulasta Inc.

Truxima approval was expected as the drug had received unanimous support from an FDA advisory group in October.

The FDA had previously refused to approve the drug, citing problems with a particular manufacturing facility.

Like Rituxan, the Truxima label contains a warning – the most severe of the agency – that highlights several health risks, including a serious and rare brain infection and liver damage.

Drug manufacturers can only produce biosimilar versions of complex drugs such as Rituxan because the molecules are made inside live cells and can not be replicated exactly.

Truxima, already approved in Europe, will be sold in the United States and Canada in partnership with Teva Pharmaceutical Industries in Israel.

Roche's drug, approved in 1997, is marketed under the names Rituxan in the United States, Japan and Canada and under the name MabThera elsewhere.

In addition to Rituxan, Roche, the world's largest producer of cancer drugs, is also competing with the biosimilars at the best price of its other two best selling drugs, Herceptin and Avastin. The Swiss-based drug maker has stepped up cost reductions to improve its efficiency.

Earlier this month, Novartis International AG had announced that it would no longer seek regulatory approval by the US for its biosimilar from Rituxan after the FDA had requested additional information.