Celltrion gets OK partial approval for phase 3 of biosimilar in Europe

South Korean biopharmaceutical company Celltrion Inc. announced on Tuesday that it has received approval from the European Medicines Agency (EMA) for Part 1 of the phase 3 clinical trial plan of the Ocrevus biosimilar CT-P53.

In this phase 3 trial, Celltrion will conduct comparative studies of efficacy, pharmacokinetics, and safety between its CT-P53 and Ocrevus, targeting a total of 512 patients with relapsing-remitting multiple sclerosis.

However, in accordance with revisions in European clinical trial regulations, this approval for the trial plan corresponds to Part 1, which includes the review of the clinical design and the drug. The actual trial can proceed only after obtaining confirmation for Part 2, which involves the review of participating countries and institutions.

Ocrevus is a blockbuster autoimmune disease treatment developed by the multinational pharmaceutical company Roche, used for the treatment of conditions like relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). As of 2022, its global sales amount to about $6.7 billion.

With the latest approval, Celltrion will proceed with CT-P53 clinical trials in the US and Europe. In the US, Celltrion obtained approval from the Food and Drug Administration (FDA) in June this year.

"Through approvals for all indications, including relapsing-remitting multiple sclerosis as well as other types of multiple sclerosis that the original product was approved for, we can expect market expansion and increased sales," a Celltrion source said. 

Write to Jeong Min Nam at peux@hankyung.com