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Celltrion gets generic antibiotic approval in U.S.

Apr 30,2019
Major Korean biosimilar manufacturer Celltrion said Monday that it has won approval from the U.S. Food and Drug Administration (FDA) for its antibiotic generic in the United States.

Linezolid is expected to go on sale in the United States by the end of the year, a move that could heat up competition in the global market, which is estimated to be worth 700 billion won ($604 million). Linezolid also received the green light from the authorities in Britain in March, with approvals expected in France, Germany, Spain and Italy, according to Celltrion.

Linezolid is an antibiotic used for infections caused by gram-positive bacteria, such as pneumonia and sepsis. It is also one of the strongest antibiotics and is especially prescribed for patients with Methicillin-resistant Staphylococcus aureus (MRSA).

The new tablet, which will be offered at a cheaper price, is expected to compete against Pfizer’s Tevox.

“The original drug costs about $180 a tablet, and the treatment is now available at a reasonable price as the patent for the original drug expired in 2015,” said a company official.