The U.S. Food and Drug Administration (FDA) has accepted Celltrion’s application to win the approval for its biopharmaceutical product for the treatment of blood cancer and rheumatoid arthritis, an antibody biosimilar Truxima (ingredient name: rituximab).
In April, Celltrion announced it had submitted to FDA documents related to Truxima’s approval concerning all its indications, including rheumatoid arthritis, non-Hodgkin’s lymphoma, and chronic lymphocytic leukemia, and filed a formal application with the FDA for a 60-day review according to the U.S. agency’s approval process.
Truxima is a biosimilar of Roche’s “MabThera,” a blockbuster drug that records more than 8 trillion won ($7 billion) in sales worldwide, with its U.S. sales last year amounting to about $4 billion, accounting for 53 percent of global sales.
Celltrion was the first of two companies to develop rituximab biosimilars in February this year and has been licensed to sell products by the European Medicines Agency (EMA).
"Following Remsima, the first antibody biosimilar approved last year by the FDA and introduced to the U.S. market, the approval of the FDA will allow Truxima to provide high-quality medical benefits to U.S. patients at a more reasonable cost,” said Kee Woo-sung, Celltrion’s CEO. “There are some procedures to be approved and released, but as in Europe, we will do our best to ensure that Truxima is approved in the United States soon."
Its U.S. distributor agreed. "We are very pleased to announce that Celltrion's Truxima U.S. license application is a step closer to American cancer patients' biosimilar treatment opportunities," said Paul Rittman, vice president of anticancer products at TEVA, a global pharmaceutical company responsible for the distribution of Truxima in the U.S.
Truxima is expected to play a major role in complementing TEVA’s unique pharmaceutical portfolio, which encompasses biopharmaceuticals and chemical drugs in areas such as cancer and rheumatoid arthritis, he added.
Celltrion has completed clinical trials of Trochima for patients with indications for hematology and rheumatoid arthritis. It also has secured prescription basis to increase product reliability from a medical system by continuing announcement of a clinical result at famous society such as the American Society of Hematology (ASH), the American Society of Clinical Oncology (ASCO), and the European Rheumatology Society (EULAR).
Truxima’s FDA approval will likely come in the first half of next year, and if approved, Celltrion will become a leader in the field of autoimmune diseases as well as oncology, the company said.
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