Teva, Celltrion win FDA approval for Rituxan biosimilar

Kare Schultz photo: PR

The companies have not announced a date for launching their version of the non-Hodgkin's Disease lymphoma treastment.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and Celltrion, its South Korean partner, have obtained marketing approval from the US Food and Drug Administration (FDA) for Truxima, a biosimilar version of Rituxan, a branded drug. Approval was granted for three forms of treatment for non-Hodgkin's Disease lymphoma. The approval comes several weeks after the FDA's oncology advisory committee unanimously recommended approval of the drug for marketing.

Biosimilar drugs are generic versions of biological drugs. Teva's drug is the first biosimilar for Rituxan. The approval is important for Teva and Celltrion, but despite the approval, the drug will not be launched immediately. Teva's announcement said that the company and Celltrion had reached a settlement with Genentech, the manufacturer of the original drug, including arrangements for entering the market. As of now, the agreement's terms are confidential.

"This is a very exciting time for biosimilars, and we expect to bring the product to market," said Teva EVP and North American commercial head Brendan O'Grady. "There is a stronger focus than ever, particularly within oncology, on bringing greater value to the healthcare system through biosimilars increasing the number of treatment options."

Teva's partnership agreement with Celltrion, which develops biosimilars, was signed in 2016. According to the $160 million licensing agreement, Teva will commercialize the biosimilar version of best-selling oncology drugs Rituxan and Herceptin, annual sales of which total $6.5 billion in the US.

Teva, managed by CEO Kare Schultz, has a $23.6 billion market cap.

Published by Globes, Israel business news - - on November 29, 2018

© Copyright of Globes Publisher Itonut (1983) Ltd. 2018 .

Kare Schultz photo: PR
Kare Schultz photo: PR
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