Truxima™, the first biosimilar mAb in oncology, granted EU marketing authorisation
- Rituximab biosimilar market entry leader ... Plans to launch in the UK in the second quarter of this year
- Truxima is anticipated in the anticancer drug market, following Remsima, the market leader in autoimmune disease therapies.
[Feb 22, 2017] Celltrion announced on Feb 22nd that it has received approval from the European Medicines Agency (EMA) to sell antibody biosimilar Truxima (Ingredient name: Rituximab), the first biosimilar mAb in oncology. The European Medicines Agency granted Truxima marketing authorization for all indications Celltrion filed for, including non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.
Truxima is Celltrion's second antibody biosimilar product for the European market, following Remsima, the world's first anticancer antibody biosimilar approved by the European Medicines Agency and a starting product for Celltrion.
Celltrion has been approved by the European Medicines Agency to sell Truxima without additional approval in 31 EU countries, including 28 EU countries such as the UK, Germany, Italy, France and Spain, and three European Economic Area (EEA) countries including Norway, Iceland and Liechtenstein.
Celltrion already completed a clinical trial for a blood cancer indication and a rheumatoid arthritis patient. Last year, the company presented clinical results at prominent societies such as The European League Against Rheumatism (EULAR) and the American Society of Hematology (ASH), which have secured the prescription basis to increase product reliability from the medical community.
Celltrion has approval for three 'First Mover' antibody biosimilar products; Truxima for European approval, Remsima (licensed in July 2012 in Korea), and Herzuma (licensed in January 2014 in Korea) and has gone into one step closer to become a global top 10 biopharmaceutical company.
Meanwhile, Celltrion is planning to file US FDA approval for Truxima and Herzuma in the first half of this year, with the aim of gaining approval before the original drug patent expires.