Teva Gets FDA Committee Nod for Rituxan Biosimilar Filing
Teva Pharmaceutical Industries Limited TEVA along with South Korean partner Celltrion Inc. announced that the FDA’s Oncologic Drugs Advisory Committee has voted unanimously (16-0) recommending approval of CT-P10, their proposed monoclonal antibody (mAb) biosimilar to Roche’s RHHBY Rituxan.
Rituxan is approved to treat Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia, Rheumatoid Arthritis, Wegener’s Granulomatosis and Microscopic Polyangiitis. However, Teva and Celltrion are seeking approval of CT-P10 for three proposed indications in NHL.
The biologics license application (BLA) will now be reviewed by the FDA. We remind investors that the FDA accepted the BLA for review in June 2017. CT-P10, if approved, will be the first Rituxan biosimilar in the United States for the three proposed indications.
Rituxan is marketed by Biogen BIIB and Genentech USA, a subsidiary of Roche.
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.
Shares of Teva have increased 11.3% year to date compared with the industry’s increase of 1.5%.
Separately, Teva presented 25-year safety data from a long-term extension study of the original pivotal study of its key multiple sclerosis drug, Copaxone. Data from the study showed that patients who continued to take Copaxone for a long time experienced acceptable safety and tolerability profile, with a smaller number of serious adverse events (SAEs) and immediate post-injection reactions (IPIRs).
Teva is facing rapid erosion in sales of Copaxone due to generic competition for the 20 mg as well as the 40 mg formulation. Novartis’ NVS generic division, Sandoz and Mylan markets generic versions of both 20 mg and 40 mg formulations of Copaxone.
Teva Pharmaceutical Industries Ltd. Price and Consensus
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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