UPDATE : Monday, June 1, 2020
FDA OKs Celltrion’s antibiotics generic
  • By Lee Han-soo
  • Published 2019.04.30 11:22
  • Updated 2019.04.30 11:22
  • comments 0

Celltrion said that the U.S. Food and Drug Administration has approved Linezolid, the company’s antibiotic generic.

Celltrion headquarters in Incheon

Linezolid is a second-generation antibiotic that uses oxazolidinone as the main ingredient and treats infections caused by gram-positive bacteria, such as methicillin-resistant staphylococcus aureus and vancomycin-resistant enterococci.

The drug is the company’s second synthetic drugs approved following Temixys, a new drug for AIDS approved by the FDA in November last year.

The company received sales approval in the U.K. for Linezolid in March and is finalizing the drug’s technology review in the four other major European markets of France, Germany, Spain, and Italy.

Also, Linezolid won WHO prequalification certification in February, and the company plans to enter the global procurement market soon.

With the increase of antibiotic resistance worldwide, the demand for linezolid is rapidly expanding. As the WHO listed the drug as a necessary treatment for multidrug-resistant tuberculosis in 2016, the procurement volume from international organizations has also been increasing three-folds every year.

Celltrion has been discussing with the “Stop TB Partnership” under the U.N. Office for Project Services (UNOPS) to provide Linezolid to international organizations and has completed the FDA’s current good manufacturing practice (cGMP) inspection for its plant in Cheongju, North Chungcheong Province, before producing it.

Celltrion plans to manufacture about 3.6 million vials of Linezolid this year through Celltrion Pharmaceuticals and plans to double its production by 2020.

“Although Linezolid was not regularly prescribed due to its high price of $180, as the patent expired in 2015, the company plans to supply generic versions of the drug at a reasonable price,” a company official said.

Celltrion plans to become a leader in the future chemical drug market as well as biopharmaceuticals by supplying high-quality generics that meets cGMP standards to the global market at competitive prices, he added.

According to IQVIA, a global health research firm, the global market for Linezolid was around 700 billion won ($601 million) in 2018. The U.S. accounts for 6 percent of the market share while the big five markets in Europe -- the U.K., Germany, France, Italy, and Spain – take up 36 percent.

Celltrion plans to release 10 more generics, including Linezolid, after completing distribution contracts with major wholesalers in the U.S. by the end of this year


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