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The Korea Herald
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THE INVESTOR
April 27, 2024

Bio

Celltrion wins FDA approval for HIV drug

  • PUBLISHED :November 19, 2018 - 16:11
  • UPDATED :November 19, 2018 - 16:11
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[THE INVESTOR] Korea’s leading biosimilar manufacturer Celltrion said on Nov. 19 that it has won approval from the US Food and Drug Administration for its tablet for treating HIV in the United States.

The tablet, called TEMIXYS, is expected to go on sale in the US early next year, a move that could heat up competition in the US HIV or AIDS treatment market, which is worth 24 trillion won (US$21.10 billion), Celltrion said.


TEMIXYS is an incrementally modified drug based on antiretroviral medication Zeffix by multinational drug firm GlaxoSmithKline Plc. and VIREAD by US biotech firm Gilead Sciences.

The new tablet, which will be offered at a cheaper price, is expected to compete with Truvada, a first-generation medication used to treat and prevent HIV or AIDS, by Gilead Sciences.

“Celltrion will make utmost effort to provide high-quality treatment to all patients suffering from AIDS based on this FDA approval,” a company official who asked not to be named, said. The market for IMDs and biosimilars has grown in recent years as they are cheaper than the originals

By Song Seung-hyun and newswires (ssh@heraldcorp.com)

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