Celltrion said in a public filing on Tuesday that it received partial approval from the European Medicines Agency (EMA) for part 1 of its global phase 3 clinical trial plan for CT-P53, its multiple sclerosis biosimilar.

As of Jan. 31, the European clinical trial regulation has been amended to integrate the European application and approval process into the EMA's Clinical Trial Information System (CTIS). As such, the clinical trial plan is divided into part 1 which reviews the study design and drug, and part 2 which reviews the participating countries and institutions.

Both parts must be approved before the trial can proceed. Celltrion submitted the phase 3 IND plan to the EMA in April this year.

Accordingly, the phase 3 global clinical trial of CT-P53 will comparatively assess the effectiveness, pharmacokinetics, and safety between CT-P53 and Ocrevus, the original drug by Roche, on 512 patients with recurrent palliative multiple sclerosis.

CT-P53 is a biosimilar to Ocrevus (ingredient:ocrelizumab). 

Ocrevus treats recurrent multiple sclerosis (RMS), and primary progressive multiple sclerosis (PPMS). It is a blockbuster product that sold about 9 trillion won (approximately $6.7 billion) globally last year. 

Celltrion plans to pursue market expansion for the biosimilar product through approval for all indications for which the original product has been approved.

Celltrion also received approval from the FDA in June for the same phase 3 IND plan.