Celltrion completed its application for the European Medicines Agency (EMA) license for the autoimmune disease treatment Humira biosimilar CT-P17 on March 6. The original CT-P17 drug Humira is a blockbuster drug that recorded $19.16 billion in global sales last year.
Celltrion has submitted clinical data based on all the indications approved for Humira, including rheumatoid arthritis, ulcerative colitis and psoriasis, and plans to introduce them to the European market once the EMA's licensing process, which usually takes about a year, is completed.
CT-P17 is the first high density biosimilar to be introduced as the Adalimumab component, and has a competitive edge from the previously released Humira biosimilar product by halving the dosage for convenience of patients.
In addition, CT-P17 has been developed to remove citrate, which can cause pain in self-injection, in line with the latest trend.
When the CT-P17 is released, Celltrion will secure a strong portfolio in the global autoimmune disease treatment market, along with Remsima IV, which has already surpassed the original drug with a 59 percent share in the autoimmune disease treatment market (third quarter of last year), and Remsima SC, which recently launched in Germany and Britain.
"We completed our application for EMA license for CT-P17 following Remsima SC, which was approved for EMA sales in November last year, and are making preparations to expand the TNF-α inhibitor market without a hitch," said an official of Celltrion.
"Since we believe that the market expectations are high and we will do our best to obtain EMA approval for early release since it is a product that was developed with differentiated marketability from previous Humira biosimilars."
Meanwhile, Celltrion plans to complete the clinical trials of its follow-up products, including CT-P17, CT-P16 and CT-P39, and complete one or more biosimilar product licenses every year by 2030.