Celltrion Healthcare Gains Positive Opinion from CHMP for Biosimilar

Celltrion Healthcare has announced, in a Dec. 10, 2020 press release, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the marketing authorization of CT-P17—an adalimumab biosimilar.

The positive opinion, which has been based on Phase I/III study data assessing the equivalence of the biosimilar to the reference product, will move forward to the European Commission (EC) for review. If CT-P17 is approved, it will be indicated for the treatment of multiple chronic inflammatory diseases, such as rheumatoid arthritis, Crohn’s disease, and uveitis.

“If CT-P17 receives approval by the EC, Celltrion will be the first company to introduce an adalimumab biosimilar with high concentration and citrate-free formulation,” said HoUng Kim, head of Medical and Marketing Division at Celltrion Healthcare, in the press release. “This portfolio expansion is in line with our mission to improve access to biologics. We aim to provide a wide range of anti-TNF treatment alternatives, together with Remsima dual formulation in IV [intravenous] formulation and SC [subcutaneous] formulation, for patients suffering from chronic inflammatory diseases.”