UPDATE : Thursday, August 13, 2020
Celltrion secures 11 generic drugs to advance to US market
  • By Lee Han-soo
  • Published 2019.12.16 17:02
  • Updated 2019.12.18 14:57
  • comments 0

Celltrion said it is speeding up efforts to enter into the U.S. market after securing approvals for 11 generic products.

Celltrion headquarters in Incheon.

According to the company, Celltrion USA has recently licensed in nine generic drugs in addition to two of its own generic drugs -- Temixys and Linezolid. With the newly added drugs, Celltrion USA now has 11 generic drugs approved by the U.S. Food and Drug Administration (FDA).

Among them, the company already launched Temixys, an incrementally modified drug for human immunodeficiency virus-1 (HIV-1), in October after reviving approval for the drug last year.

It is also discussing with a large wholesaler for its generic super antibiotic Linezolid. Linezolid is a generic version of Pfizer's Zyvox, which is used to treat antibiotic-resistant bacteria and tuberculosis. The drug received FDA approval in April.

Other generics licensed in by the company treat hypersensitive bladder, diabetes, and cancer.

"We are in talks with a large wholesaler to release the rest of our products following the launch of Temixys in October," a company official said. "The 11 secured products be sold directly from Celltrion USA as part of its 'Global Chemical Project,' aiming to expand its business from biopharmaceuticals to generic drugs."


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