MEDI:GATE NEWS Celltrion submits phase 3 clinical trial plan for interchangeability between CT-P17 and Humira to the US FDA

Celltrion announced to the U.S. Food and Drug Administration (FDA) on the 29th (local time) to secure interchangeability between the autoimmune disease treatment CT-P17 (ingredient name: adalimumab, product name: Uplyma) and the original drug Humira. A phase clinical trial plan (IND) was submitted.

Celltrion plans to conduct a global phase 3 clinical trial for 366 patients with plaque psoriasis, and plans to compare and verify the pharmacokinetics, efficacy, and safety between the group that took multiple doses of Euplasma and Humira and the group that maintained Humira.

UPLYMA is the world’s first high-concentration Humira biosimilar approved by the European Medicines Agency (EMA).

Humira received approval for all indications owned by Humira, including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis (PS), and started sales in major European countries, and started the sales process in Korea in March. In order to start sales in the United States from July 1, next year, the FDA has completed an agreement for a patent in the United States with Abbvie, the original developer, and is expecting approval from the FDA within this year.

Celltrion plans to secure Humira’s interchangeable biosimilar status in the U.S. through interchangeable clinical trials in addition to the advantages of U-Pyma’s high-concentration formulation and expand its market share in the U.S. and other global markets.

A Celltrion official said, “If U-Pyma, which is planning to launch next year in the US, the world’s largest drug market, as an interchangeable biosimilar, can replace the original drug with a prescription from a pharmacist at pharmacies. “We will do our best to prepare for the launch of sales in the U.S. market so that we can provide high-quality biopharmaceuticals to U.S. medical staff and patients at a reasonable price.”