Celltrion wins phase 3 IND approval for Ocrevus biosimilar in US

South Korea's biopharmaceutical company Celltrion Inc. announced that it received on Thursday approval from the US Food and Drug Administration (FDA) for the phase 3 investigational new drug (IND) application of its biosimilar CT-P53 for Ocrevus (ingredient: ocrelizumab), a treatment for multiple sclerosis.

This IND approval was obtained approximately a month after Celltrion submitted the global phase 3 IND plan for CT-P53 to the FDA in May. The company plans to conduct comparative studies on efficacy, pharmacokinetics and safety between CT-P53 and the original drug Ocrevus in a total of 512 relapsing-remitting multiple sclerosis patients.

The original drug of CT-P53, Ocrevus, is a blockbuster autoimmune disease treatment developed by Roche. It is used for the treatment of relapsing-remitting multiple sclerosis and primary progressive multiple sclerosis. Ocrevus recorded global sales of approximately $7 billion as of last year. It holds the top position in the global multiple sclerosis market, with the US market accounting for over 70% of the total market size at $5.2 billion.

"With the clinical approval of our new pipeline product CT-P53 in the United States, we are entering the main clinical process and preparing for entering the US ocrelizumab market, which is estimated to be over $4.7 billion," a Celltrion official said. "We will do our best to accelerate the phase 3 clinical trials and make CT-P53 a first mover in the Ocrevus biosimilar market."

Celltrion plans to complete the application for approval of up to five biosimilars, including CT-P39 (Xolair), CT-P43 (Stelara), CT-P42 (Eylea), CT-P41 (Prolia) and CT-P47 (Actemra), within this year. The company aims to expand its biosimilar product portfolio to 11 items by 2025.

Write to Jeong Min Nam at peux@hankyung.com