Posted by Michael Wonder on 27 Feb 2023
Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma (CT-P17), in the US, saying there were some problems, but they have been solved now
24 February 2023 - Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma (CT-P17), in the US, saying there were some problems, but they have been solved now.
In a letter to shareholders published on its website Thursday, Celltrion said it has acquired a sales permit for Yuflyma from the EMA and the Korean Ministry of Food and Drug Safety and is selling it while waiting for approval from the US regulator.
