UPDATE : Saturday, February 22, 2020
FDA OKs sale of Celltrion's HIV biosimilar
  • By Lee Han-soo
  • Published 2018.11.21 12:57
  • Updated 2019.11.21 09:35
  • comments 0

Temixys, a generic developed by Celltrion to treat the human immunodeficiency virus (HIV), has won sales approval from the U.S Food and Drug Administration.

Currently, the market for HIV drugs in the U.S. is about 24 trillion won ($21.1 billion). The company plans to compete in the Gilead’s Truvada market, which is nearly 3.3 trillion won.

Celltrion began to develop Temixys in 2016, as a combination of GSK's original antiviral drug Zeffix (Ingredient: lamivudine) and Gillard's antiviral drug Viread (Ingredient: Tenofovir). The company applied for U.S. approval in January.

Celltrion had previously obtained a license to export the drug from the Ministry of Food and Drug Safety on Oct. 25. With the FDA approval, the company plans to launch the treatment in the U.S. early next year.

Celltrion plans to preempt the HIV treatment market by supplying a high-quality chemical therapy at a reasonable price compared to the original drug to HIV patients who have difficulties obtaining medicines due to its high price and insurance structure of the U.S.

Also, the Korean company will secure the supplier qualification to the global procurement market, such as the Global Fund, which is a significant HIV treatment provider in the world, including the World Health Organization, U.S. Agency for International Development (USAID) and the United Nations Development Program (UNDP).

“The successful global launch of Remsima, the world's first antibody biosimilar, and its successors, Truxima and Herzuma, has enabled us to provide affordable, high-quality biosimilar treatment benefits to patients worldwide,” a company official said. “Based on the FDA approval of Temixys, we will do our best to supply high-quality remedies early on to patients who have HIV.”


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