Celltrion unveils phase 1 clinical data of Actemra biosimilar in Europe

South Korean biosimilar giant Celltrion Inc. revealed on Wednesday the highly anticipated clinical phase 1 data for its Actemra biosimilar, CT-P47, at the 2023 European Congress of Rheumatology (2023 EULAR) conference.

Actemra, a subcutaneous injection (SC) formulation developed by Roche, generated sales worth $3.4 billion last year. EULAR, recognized as the world's most prestigious rheumatology society, commenced its annual conference in Milan, Italy, on the same day and will continue until June 3.

The clinical data for CT-P47 was made available online by Celltrion, following a phase 1 study involving 318 health South Korean subjects. The company announced that it had successfully demonstrated pharmacodynamic (PK) equivalence and safety comparable to the original drug.

CT-P47 is indicated for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome.

In addition to the subcutaneous injection formulation, Celltrion is developing CT-P47 in an intravenous injection (IV) formulation to offer flexibility to medical professionals when prescribing the treatment, based on patient conditions and convenience. The IV formulation has been undergoing global phase 3 trials since July of last year.

Actemra, a biopharmaceutical designed to inhibit the interleukin-6 protein responsible for inflammation in the body, has already expired its substance patent, though the formulation patent remains valid for a period of time. The launch of Actemra biosimilar CT-P47 is scheduled for the second half of next year.

Celltrion anticipates that the introduction of CT-P47 will further strengthen its product portfolio, distinguishing itself from other autoimmune disease biosimilars such as Remsima currently available in the market.

Remsima, a tumor necrosis factor (TNF-α) inhibitor, stands in contrast to CT-P47, which functions as an interleukin inhibitor.

Write to Yoo-Rim Kim at youforest@hankyung.com