Teva and Celltrion Partner on Biosimilar Commercialization

October 6, 2016

The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.

On Oct. 6, 2016, Teva Pharmaceuticals and Celltrion Healthcare announced that they have entered into a partnership to commercialize two of Celltrion’s monoclonal antibody (mAb) biosimilar candidates in the United States and Canada. The companies are collaborating on two of Celltrion’s mAb biosimilar candidates CT-P10 and CT-P6.

CT-P10 is a proposed biosimilar to Rituxan (rituximab), which is a mAb used to treat patients with Non-Hodgkin’s Lymphoma (NHL), chronic lymphocytic leukemia, rheumatoid arthritis, Wegener’s Granulomatosis, and Microscopic Polyangiitis. CT-P6 is a proposed biosimilar to Herceptin (trastuzumab), which is used for the treatment of HER2-overexpressing breast cancer and for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Combined annual net sales for Rituxan and Herceptin are approximately $6.5 billion in the US and Canada.

Both CT-P10 and CT-P6 are currently in late-stage Phase III development and their primary endpoints have been achieved. CT-P10 was submitted by Celltrion to the European Medicines Agency (EMA) for review in October 2015. Celltrion says it is preparing CT-P6 for submission in Europe seeking approval from the EMA this quarter. As part of the agreement, Teva will be responsible for all commercial activities in the US and Canada, pending regulatory approvals for both products. Celltrion has responsibility for completing all clinical development and regulatory activities.

Under the terms of the agreement, Teva will pay Celltrion Healthcare $160 million upfront, of which up to $60 million is refundable or creditable under certain circumstances. Teva and Celltrion Healthcare will share profit from the commercialization of the mAb biosimilars.

Source: Teva Pharmaceuticals