Celltrion set to win EC approval for biosimilar to Humira medicine

Celltrion scientists work on a Humira biosimilar medicine at the company's research center in Songdo, Incheon. / Courtesy of Celltrion

By Kim Hyun-bin

Celltrion received a sales approval recommendation from the European Medicine Agency (EMA) for its CT-P17 drug, Thursday local time.

The recommendation came from the EMA's Committee for Human Medical Products (CHMP).

CHMP is an organization within the EMA that conducts scientific evaluation of a new medicine and submits an approval recommendation. This is practically considered a sales approval.

CT-P17 is a biosimilar of Humira and used to treat a range of illnesses, including rheumatoid arthritis. It will become the first of the high-level Humira biosimilar drugs to be introduced in the European market.

Celltrion has differentiated the drug from existing Humira biosimilars by cutting the dose rate in half. It also has removed citrate that can cause pain for patients.

The company has been able to enter the high-level Humira market when other biosimilar products failed to do.

Once CT-P17 is formally approved and sales start to pick up, the company will likely go through a restructuring to adapt to market demand.

The approval comes nine months after Celltrion applied in March.

The European Commission (EC) usually gives final sales approval within three months of CHMP's sales recommendation.

Once Celltrion is given the green light, Celltrion Healthcare, which is responsible for global marketing and distribution, will register CT-P17 in various countries and introduce it in the European market.

“We will prepare to launch CT-P17 in Europe after it gets final approval in the first quarter next year and we aim to better target the autoimmune disorder market,” a Celltrion official said.