Celltrion looks to expand biosimilar line by 2025

Celltrion headquarters in Songdo, Incheon [CELLTRION]

Celltrion hopes to submit drug approval applications for up to five new biosimilars by the end of this year, the Incheon-based biopharmaceutical company said Tuesday.

Biosimilars, according to the U.S. Food and Drug Administration (FDA), are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful difference in safety or effectiveness from the reference product, but they cost less.

With the potential addition of these new drugs, Celltrion could increase its biosimilar product line from the current six to 11 by 2025.

Celltrion filed an application for sale approval for CT-P43, its biosimilar to Stelara, Janssen Pharmaceutical's psoriasis treatment, in Europe in May, and for CT-P39, a biosimilar referencing allergic asthma treatment Xolair, in April.

The company also plans to submit an application for CT-P42, a drug referencing eye treatment Eylea, to the U.S. regulator in June.

Phase 3 clinical trials for CT-P41, a drug referencing osteoporosis treatment Prolia, and CT-P47, Celltrion's biosimilar to rheumatoid arthritis treatment Actemra, are currently ongoing. The company also submitted an application for a phase 3 clinical trial for CT-P53, a biosimilar to Roche’s multiple sclerosis drug Ocrevus, to regulators in the United States and Europe.

Celltrion aims to file drug approval applications for its biosimilar products that are currently in clinical trials by the end of the year.

The company estimates the combined market size of its six biosimilar products that are currently available for sale and the five upcoming new drugs will reach some 100 trillion won ($78.5 billion).

“By submitting and gaining approvals for the next-generation biosimilar drugs, we are continuously striving to expand our pipelines and bolster the biosimilar business,” said a Celltrion spokesperson.

BY SHIN HA-NEE [shin.hanee@joongang.co.kr]