Celltrion Healthcare, the marketing, sales, and distribution arm of Celltrion, an Incheon, South Korea-based pharmaceutical company, has received approval from the European Commission for Truxima (rituximab), a biosimilar to Roche’s MabThera/Rituxan (rituximab), for all indications of the reference drug in the European Union (EU). MabThera/Rituxan is Roche’s top-selling drug with 2016 sales of CHF 7.3 billion ($7.3 billion).

Truxima, a monoclonal antibody (mAb) that targets CD20, a protein found on the surface of most B cells, is approved in the EU for treating non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

Celltrion is partnered with Teva Pharmaceutical Industries for the marketing of Truxima. In October 2016, the companies formed an exclusive partnership to commercialize Truxima and another biosimilar candidate in the US and Canada. Under the agreement, Teva paid Celltrion Healthcare $160 million upfront and will share profit from the commercialization of both mAb biosimilars. 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.

In addition to Celltrion’s biosimilar program for rituximab, Mabion, a Konstantynów Łódzki, Poland-based biopharmaceutical company, is also developing a biosimilar to the same product. Mabion partnered with Mylan in November 2016, signing a long-term development and commercialization agreement, giving Mylan exclusive rights to Mabion’s biosimilar candidate to Roche’s MabThera/Rituxan in all EU countries and non-EU Balkan states. Mylan will support Mabion in Mabion’s effort to secure approval from the European Medicines Agency for its biosimilar. Under the agreement and subject to certain conditions, Mylan will pay Mabion an upfront payment of $10 million and additional milestone payments in the aggregate of up to $35 million, subject to filing and approval of marketing authorizations and commercial launch in key countries as well as royalties based on annual net sales.

Source: Celltrion Healthcare