UPDATE : Monday, September 7, 2020
Celltrion to start P1 trial of Prolia biosimilar
  • By Lee Han-soo
  • Published 2020.08.14 15:32
  • Updated 2020.08.14 15:32
  • comments 0

Celltrion said that it would start phase 1 clinical trial of CT-P41, a Prolia biosimilar, from September.

Celltrion plans to start phase 1 clinical trial into a biosimilar for Prolia from September. (Celltrion)

Prolia, developed by Amgen, is a monoclonal antibody injection that targets Receptor Activator of Nuclear factor Kappa-B Ligand (RANKL) proteins in osteoporosis patients. According to Amgen's annual report, the drug's sales reached 3.2 trillion won ($2.6 billion) in 2019.

With the launch of the trial, the company aims to begin a global phase 3 clinical trial by the first half of next year and prepare for commercialization by February 2025, which is when Prolia's U.S. substance patent expires.

Celltrion expects that CT-P41 will become the firm's future growth drive as well as CT-P17, a Humira biosimilar currently undergoing review by the European Medicines Agency, CT-P16 (Avastin biosimilar), CT-P39 (Xolair biosimilar), and CT-P43 (Stelara biosimilar).

"The company is developing osteoporosis treatments to further expand its product portfolio along with existing autoimmune and anticancer treatments such as Remsima, Truxima, and Herzuma," a company official said. "We plan to stably supply high-quality biosimilar products at reasonable prices by introducing products to big global markets such as the U.S. and Europe."


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