UPDATE : Monday, July 13, 2020
Celltrion starts P1 trial of Xolair biosimilar
  • By Lee Han-soo
  • Published 2019.07.15 17:45
  • Updated 2019.07.15 17:45
  • comments 0

Celltrion said Monday that it initiated the phase 1 clinical trial of CT-P39, a Xolair biosimilar.

Celltrion headquarters in Incheon

Xolair is a blockbuster product developed by Genentech and Novartis for the treatment of allergic asthma and chronic urticaria. According to IQVIA, the global sales of the drug reached 3.3 trillion won ($2.7 billion) in 2018.

During the phase 1 clinical trial, Celltrion plans to conduct safety and pharmacokinetic evaluations for the drug. The company also aims to enter into phase 3 clinical trials in the first half of 2020 and commercialize it by 2022. Celltrion began developing the CT-P39, after realizing that the drug's patent expired in the U.S. in December 2018. The U.S. market accounts for 70 percent of Xolair's global sales.

"Xolair was designated as an innovative drug by the FDA last year, while the original drugmaker is also trying to expand the indications based on product's innovation," a company official said. "Celltrion will do its best to acquire first-mover status for Xolair biosimilar so that more patients can receive treatment at a reasonable cost soon."

The Korean company plans to continue conducting global drug market research to expand its antibody-drug portfolio in addition to its autoimmune diseases and anticancer drugs, he added.


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