Teva, Celltrion to commercialize biosimilars to Rituxin, Herceptin
Teva Pharmaceuticals Industries Ltd., Celltrion Inc. and Celltrion Healthcare recently announced an exclusive partnership to commercialize biosimilars to Rituxin and Herceptin, according to a company press release.
“Following on the heels of our global success with Remsima (Inflectra), our infliximab biosimilar, which has brought affordable and effective biologic treatment to many patients around the world with [a] proven record of quality, efficacy and safety to the reference product, we are confident that we will be able to repeat the same success in the [United States] U.S. and Canada with CT-P10 and CT-P6 through our partnership with Teva,” HyoungKi Kim, chief executive officer of Celltrion Inc., said in the release.
According to the release, CT-P10 — the proposed monoclonal antibody (mAb) biosimilar to Rituxin (rituximab, Genentech) — is used to treat patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Wegener’s Graunolomatosis and Microscopic Polyangiitis.
CT-P6 — the proposed mAb biosimilar to Herceptin (trastuzumab, Samsung Bioepis Co.) — is used to treat patients with HER2-overexpressing breast cancer and adenocarcinoma.
Both drugs are undergoing phase 3 trials in which the primary endpoints have been achieved. Celltrion submitted CT-P10 to the European Medicines Agency for review in October 2015 and is preparing to do the same for CT-P6.
In the agreement, Teva will be responsible for commercial activities, while Celltrion will be responsible for completing clinical development and regulatory activities. In the terms of the agreement, Teva will provide an upfront payment to Celltrion Healthcare of $160 million, of which $60 million is refundable or creditable. In addition, both companies will share profits from the commercialization of the biosimilars.
“The introduction of two additional mAb biosimilar candidates into our near-term pipeline bolsters our biosimilar portfolio and continues to leverage Teva’s unique cross-functional capabilities across both specialty and generic medicines,” Siggi Olafsson, president and chief executive officer of Global Generic Medicines at Teva, said in the release.