Celltrion wins FDA approval to sell Linezolid antibiotic for bacterial infections and tuberculosis

[Celltrion]

SEOUL --Celltrion, a biopharmaceutical company in South Korea, has secured approval from the U.S. Food and Drug Administration to sell its biosimilar Linezolid, an effective antibiotic for bacterial infections and tuberculosis.

Ceilltrion said Monday it would produce 3.6 million linezolid tablets and double production by 2020.

Linezolid is an antibiotic used for the treatment of infections caused by Gram-positive bacteria that are resistant to other antibiotics. It is active against most Gram-positive bacteria that cause disease, including streptococci, vancomycin-resistant enterococci (VRE), and methicillin-resistant Staphylococcus aureus (MRSA).

Linezolid, approved in Britain in March, was pre-qualified by the World Health Organization in February. It can be used mainly to treat infections of the skin and pneumonia although it may be used for a variety of other infections including drug-resistant tuberculosis.

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.

Lim Chang-won cwlim34@ajunews.com

Celltrion wins FDA approval to sell Linezolid antibiotic for bacterial infections and tuberculosis

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