[Asia Economy Reporter Lee Junhyung] Celltrion announced on the 11th that it has received a recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for ‘CT-P17,’ a biosimilar of Humira, an autoimmune disease treatment, for 30 European countries.


CT-P17 is the first biosimilar of Humira developed in a high-concentration formulation and has removed citrate, which can cause pain to patients.



Celltrion stated, "With this recommendation for approval, we expect the European Commission (EC) to grant final approval in the first half of next year," adding, "Once the EC grants final authorization, CT-P17 will be marketed throughout Europe through Celltrion Healthcare."


This content was produced with the assistance of AI translation services.

© The Asia Business Daily(www.asiae.co.kr). All rights reserved.

Today’s Briefing