Celltrion said on Monday that it submitted a phase 3 investigational new drug (IND) plan to the U.S. Food and Drug Administration (FDA) for CT-P53, a biosimilar of the multiple sclerosis drug, Ocrevus (ingredient: ocrelizumab).

The phase 3 global clinical trial of CT-P53 will be a comparative study on the effectiveness, pharmacokinetics, and safety between CT-P53 and Ocrevus on 512 patients with recurrent palliative multiple sclerosis.

In April, Celltrion submitted the IND plan to the clinical trials information system (CTIS) managed by the European Medicines Agency (EMA).

Ocrevus is a blockbuster autoimmune disease treatment developed by Roche and is used to treat recurrent multiple sclerosis (RMS), and primary progressive multiple sclerosis (PPMS).

As of 2022, Ocrevus has maintained its sales as the number one product in the multiple sclerosis market with global sales of about 9 trillion won (7.4 billion won). Among this figure, the U.S. market represents 6.66 trillion won, accounting for more than 70 percent of the total global market.

"We plan to accelerate the development of the product based on the unique experience and know-how accumulated in the field of autoimmune diseases by submitting the IND of CT-P53 to global regulators," said a Celltrion official.

Meanwhile, Celltrion plans to further strengthen its core businesses and is preparing market authorization for five biosimilars this year, including Xolair biosimilar CT-P39, Stelara biosimilar CT-P43, Eylea biosimilar CT-P42, Prolia biosimilar CT-P41, and Actemra biosimilar CT-P47.