Generic drug maker Teva Pharmaceutical Industries Ltd. (TEVA - Analyst Report) has entered into an exclusive biosimilar commercial partnership with Korean biopharmaceutical company Celltrion, Inc and its distribution partner Celltrion Healthcare.
Per the deal, Teva gets exclusive rights to commercialize two of Celltrion’s phase III biosimilar monoclonal antibodies (mAbs) biosimilar candidates – CT-P10 and CT-P6 – in the U.S. and Canada, pending regulatory approvals. Celltrion will, however, be responsible to finish off their clinical development and regulatory formalities.
CT-P10 is a proposed mAb biosimilar to Roche Holding AG’s (RHHBY - Analyst Report) drug Rituxan (rituximab) which is approved to treat non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia, rheumatoid arthritis, Wegener’s Granulomatosis and Microscopic Polyangiitis. CT-P6, on the other hand, is a proposed mAb biosimilar to Roche’s key breast cancer drug Herceptin (trastuzumab).
Both the candidates have met their primary endpoints in the respective late-stage phase III studies. While CT-P10 is under review in the EU, CT-P6 is planned to be submitted for review to the European Medicines Agency (EMA) this quarter.
Per the financial terms of the deal, Teva will pay Celltrion Healthcare $160 million upfront. Once the mAb biosimilars are commercialized, Teva and Celltrion Healthcare will share profits from the same.
The deal is in line with Teva’s plans to strengthen its biosimilar pipeline. In fact, the pharmaceutical industry is set to see an approaching wave of biosimilars, which are essentially generic versions of expensive biologic drugs.
Several pharma as well as biotech companies are involved in the development of biosimilars. The first biosimilar to gain approval in the U.S. was Sandoz’s (Novartis AG’s (NVS - Analyst Report) generic arm) Zarxio, a biosimilar version of Amgen Inc.’s (AMGN - Analyst Report) Neupogen.
Other approved biosimilars include Pfizer’s Inflectra, a biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab) and Sandoz’s Erelzi, a biosimilar to Amgen’s Enbrel (etanercept). Last month, Amgen’s biosimilar version of Abbvie’s Humira – Amjevita – gained FDA aaproval.
Several other companies like Merck, Pfizer, Biogen and Allergan are targeting the highly lucrative biosimilars market.
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