Celltrion, Recommended for European Approval to Sell 'Humira' Biosimilar

"Differentiated by Solid Dosage Form"... Approval Targeted for Q1 Next Year

[Asia Economy Reporter Cho Hyun-ui] Celltrion's autoimmune disease treatment 'Humira' biosimilar 'CT-P17' has received a recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).

On the 11th, Celltrion announced, "It has been 9 months since we applied for CT-P17 approval to the EMA last March for all indications (treatment scopes) that Humira covers, including rheumatoid arthritis, inflammatory bowel disease, and psoriasis, and we have now received a recommendation for marketing authorization from the CHMP."

CT-P17 is a high-concentration biosimilar of adalimumab, which will be introduced to the European market for the first time. It is differentiated by a formulation that halves the drug dosage and removes 'citrate,' which can cause pain.

Humira, developed by multinational pharmaceutical company AbbVie, is a blockbuster drug that recorded sales of $19.169 billion (approximately 22 trillion KRW) last year. Since the substance patent expired in Europe in 2018, several companies have launched Humira biosimilars.

Celltrion, noting that all existing Humira biosimilar products were launched at low concentrations, has introduced the world's first high-concentration formulation. Celltrion stated, "AbbVie's high-concentration formulation launched in 2016 currently accounts for more than 90% of Humira's sales in Europe," and added, "Once CT-P17 sales begin in earnest, the biosimilar market will also be reorganized around high-concentration formulations."

The European Commission (EC) typically grants final marketing authorization within 1 to 3 months after CHMP's recommendation. After completing the approval process, Celltrion plans to introduce CT-P17 to the European market through Celltrion Healthcare, which is responsible for global marketing and distribution, following the process of drug price listing by country.

A Celltrion official said, "Based on the know-how of Remsima IV and Remsima SC, which recorded market shares surpassing the original drugs in Europe, we will prepare smoothly for CT-P17 approval in the first quarter of next year."