April 18, 2024

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Celltrion Group on Sept. 20 announced that European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended giving sales approval for Remsima SC.

CHMP is responsible for preparing the opinions to EMA on questions concerning human medicines based on scientific evidence. 

According to the Korean company, it now has high expectations to successfully receive sales approval in Europe following CHMP’s recommendation.

Remsima SC is a subcutaneous version of Remsima, the Korean company’s biosimilar of Johnson & Johnson’s autoimmune disease therapy Remicade. According to the company, the new pen-type Remsima will enable patients to inject the therapy by themselves without visiting a hospital.

In November last year, the company applied for the sales approval of Remsima SC in Europe. The drug has been going through a different process to receive the approval of its sale as it is considered as biobetter product, which is different from biosimilar as it improved from the original drug in a significant way.

“The further development of the Infliximab SC formulation is a significant challenge that even the original company has not yet succeeded in. It is also our key strategic product to leap forward as a global pharmaceutical biotechnology company,” a Celltrion official said in a statement.

The Korean health care company anticipates its sales of Remsima SC to exceed 10 trillion won ($8.2 billion) once it begins sales in Europe, as no competitor provides a subcutaneous version of Remicade in the market.

By Song Seung-hyun (ssh@heraldcorp.com)