Celltrion's Biosimilar Granted Marketing Approval Recommendation

South Korea’s Celltrion Inc., has said the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization to its Truxima (rituximab), a biosimilar to Roche’s Rituxan, which is indicated for blood cancer. The recommendation, issued last Friday is based on data from various studies that showed Truxima is bioequivalent to its reference drug Rituxan in safety and efficacy.

Market authorization usually follows the recommendation two to three months later, which was made by experts who reviewed efficacy and safety data of the drug. The EMA’s approval is equally effective in 27 European Union members and three European Economic Area countries - Norway, Iceland and Lichtenstein.

The recommendation for Truxima is applied to all indications of its reference drug, which include non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

Truxima was approved in Korea last month. The manufacturer aims to receive approval in Europe early next year and to plan to submit a New Drug Application (NDA) with the U.S. counterpart FDA in the first half of next year.

“We are working to launch Truxima in Europe with an anticipated milestone of regulatory approval early next year. The milestone will serve as an opportunity to reaffirm our vision to play as a first mover in the market and achieve 10 trillion won ($8.42 billion) in sales within 10 years and join the the top 10 list of global biotech companies,” said Celltrion president Kim Hyung-ki.