Teva receives FDA nod for Rituxan biosimilar cancer drug

Teva Photo: ASAP Creative Shutterstock

If the FDA approves CT-P10 for marketing, this will be the first biosimilar generic version of Rituxan.

Good news for Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA). The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee has voted unanimously to recommend approval of CT-P10, a proposed monoclonal antibody biosimilar to Rituxan (rituximab) for the treatment of various forms of cancer.

If the FDA approves CT-P10 for marketing, this will be the first biosimilar generic version of Rituxan. Celltrion and Teva entered into an exclusive partnership in October 2016 to commercialize CT-P10 in the US and Canada.

Teva EVP and Head of North America Commercial Brendan O'Grady said, “If approved, Teva is well positioned to successfully commercialize CT-P10, given our unique portfolio of branded and generic medications, as well as patient support experience. We are encouraged by the outcome of today’s meeting, which emphasizes the growing importance of biosimilars and the potential value to be introduced into our health systems.”

Celltrion CEO Woosung Kee said, “We welcome the Oncologic Drugs Advisory Committee’s recommendation. If approved by the FDA, CT-P10, a proposed biosimilar to Rituxan, will be the first rituximab biosimilar to be approved in the US for the three proposed indications. The development of biosimilars is of great importance in the field of oncology, and has the potential to increase accessibility to therapies for patients.”

Published by Globes [online], Israel business news - en.globes.co.il - on October 11, 2018

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

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Teva Photo: ASAP Creative Shutterstock
Teva Photo: ASAP Creative Shutterstock
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