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August 26, 2019

Celltrion to ignite Remsima SC’s phase 3 clinical trial in US

PUBLISHED : August 01, 2019 - 14:49

UPDATED : August 01, 2019 - 14:51

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Celltrion announced on Aug. 1 that it had started a phase 3 clinical trial of its new drug Remsima SC in the US.

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 with mild conditions to inject the therapy by themselves without visiting a hospital.




At the beginning of this year, Remsima SC was exempted from phase 1 and 2 clinical trials by the US Food and Drug Administration, after the company submitted clinical trial data from its application in November for approval by the European Medicines Agency.

According to the company, it recently started recruiting patients for the clinical trial in Ohio. The company hopes to finish the injection formula’s phase 3 clinical trial by 2021.

Celltrion also expects the new version to encompass patients with inflammatory bowel disease who are being treated with other anti-tumor necrosis factor-alpha, or TNF-alpha, therapies including AbbVie’s Humira, Amgen’s Enbrel, as well as the original Remicade. The combined market size of TNF-alpha inhibitor therapies last year stands at around 43 trillion won ($36.2 billion).

“We aim to develop Remsima SC as a global blockbuster product that can surpass sales of the world’s top-selling drug Humira,” a Celltrion official said in a statement. Humira is AbbVie’s anti-inflammatory drug that generated sales of around 23 trillion won in 2018.

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

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