Celltrion Healthcare's adalimumab biosimilar in last step before EC approval

Celltrion announced Friday that the company’s adalimumab biosimilar candidate CT-P17 has received a positive opinion for marketing authorization from the Committee for the Medicinal Products for Human Use under the European Medicines Agency.

Celltrion’s CT-P17 is a biosimilar of Humira, a treatment for autoimmune and inflammatory diseases such as rheumatoid arthritis, ulcerative colitis and psoriasis.

The CHMP’s positive assessment will be soon reviewed by the European Commission, which has the authority to approve medicines for the European Union. It usually takes one to three months before the commission’s final approval, according to industry sources.

When approved, Celltrion will become the first company to introduce an adalimumab biosimilar with high concentration and citrate-free formulation in the European market, according to the company.

Celltrion submitted the application for CT-P17 to the EMA in March.

By Shim Woo-hyun (ws@heraldcorp.com)