Celltrion, a leading biopharmaceutical company, has announced on June 15th (KST) that it has received regulatory approval from the U.S. Food and Drug Administration (FDA) for the Phase 3 clinical trial plan (IND) of its biosimilar product called 'CT-P53'. This innovative biosimilar is specifically developed as a treatment for multiple sclerosis, targeting Ocrevus (active ingredient: Ocrelizumab).

The approval for the Phase 3 clinical trial plan follows Celltrion's submission of the global Phase 3 IND for CT-P53 to the FDA in May, demonstrating the company's commitment to advancing the development of this biosimilar. Celltrion intends to conduct comprehensive comparative studies to evaluate the efficacy, pharmacokinetics, and safety of CT-P53 in comparison to the original drug Ocrevus. The clinical trials will involve a cohort of 512 patients diagnosed with relapsing-remitting multiple sclerosis (RRMS).

Ocrevus, the reference drug and a highly successful autoimmune disease treatment, is a biosimilar of CT-P53 developed by Roche, a prominent Swiss pharmaceutical company. It is widely prescribed for the management of relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Notably, Ocrevus has achieved remarkable global sales, reaching approximately $9 billion last year, solidifying its position as the leading drug in the global multiple sclerosis market. The U.S. market alone accounts for more than 70% of the overall market, representing a staggering $6.66 billion.

Commenting on this significant milestone, a Celltrion official stated, "With the U.S. clinical approval of our pioneering pipeline product, CT-P53, we are now entering the full-scale clinical phase and actively preparing for market entry in the United States, with projected sales exceeding 6 billion dollars." The official further emphasized, "We are committed to expediting the Phase 3 clinical trials and endeavoring to establish CT-P53 as the foremost biosimilar in the competitive Ocrevus market."