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Teva's Rituxan Biosimilar Gets FDA Nod in Non-Hodgkin Lymphoma

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Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) and its South-Korean partner Celltrion announced that the FDA has approved their monoclonal antibody (mAb) biosimilar to Roche’s (RHHBY - Free Report) blockbuster cancer drug, Rituxan (rituximab). The biosimilar will be available in the United States by the trade name of Truxima (CT-P10)

Rituxan is approved to treat Non-Hodgkin’s lymphoma (“NHL”), chronic lymphocytic leukemia, rheumatoid arthritis, Wegener’s granulomatosis and microscopic polyangiitis. However, Teva’s Truxima has received approval for only three NHL indications. Rituxan is marketed by Biogen (BIIB - Free Report) and Genentech USA, a subsidiary of Roche.

Truxima is the first Rituxan biosimilar to get approval in the United States for the indications mentioned above.

Shares of Teva have increased 15.3% year to date against the industry’s decrease of 10.6%.

 

In October 2016, Teva entered into an exclusive biosimilar commercial partnership with Celltrion, gaining exclusive rights to commercialize two of Celltrion’s mAbs biosimilar candidates — CT-P10 and CT-P6 — in the United States and Canada.

CT-P6 is a proposed mAb biosimilar to Roche’s key breast cancer drug, Herceptin (trastuzumab). The candidate is under review in the United States.

Per the financial terms of the deal, once the mAb biosimilars are commercialized, Teva and Celltrion will share the profits. Rituxan has recorded sales of nearly $3.3 billion in the first nine months of 2018, which reflects significant market for its biosimilars. However, adoption of Truxima in NHL indication remains to be seen.

We remind investors that Novartis (NVS - Free Report) has already launched its biosimilar version of Rituxan/ MabThera in Europe. It has given a significant boost to the company’s Biopharmaceuticals segment. However, Novartis received a complete response letter from the FDA in May 2018 for its regulatory application looking for approval of Rituxan biosimilar in the United States, Earlier this week, Teva announced the launch of the generic version of Mylan’s allergy treatment, EpiPen in the United States.

Zacks Rank

Teva currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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