SEOUL -- Celltrion, a major bio firm in South Korea, has acquired recommendations for the sale of Remsima SC, the subcutaneous injection of Remsima, a copy of Janssen Biotech's Remicade treating rheumatoid arthritis, in Europe. Final approval would provide an opportunity for Celltrion's dramatic growth in the global pharmaceutical market.
Remsima SC, which is an evolved version of biosimilars, is aimed at enhancing patient convenience and access to medical care. Instead of an intravenous injection that takes more than two hours in hospital, patients can inject Remsima SC into the fat layer beneath the skin at home.
Celltrion said that Remsima's 120 mg solution for injection in a pre-filled syringe or pen has won sales approval recommendations from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA).
"We expect final EMA approval by the end of this year," the company said in a regulatory filing on Monday, adding that direct sales in Europe would be made by Celltrion Healthcare, which is responsible for overseas marketing and distribution, if Remsima SC secures final approval. Celltrion expects sales of Remsima SC to exceed 10 trillion won ($8.4 billion) in Europe.
Celltrion said that authorization would be sought to add an indication for other diseases such as Crohn's disease, ulcerative colitis and psoriatic arthritis.
With Remsima SC, Celltrion has adopted an aggressive strategy to secure profitability and price penetration in competition with other SC-type products such as Adalimumab, sold under the brand name of Humira. Remsima SC is seen as a key strategic product for Celltrion's leap into a global pharmaceutical bio company.
Celltrion's biosimilars include Herzuma, based on Herceptin developed by Genentech, a subsidiary of Swiss pharmaceutical giant Roche. Truxima, the first biosimilar to Rituxan (rituximab), treats patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis.
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