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Remsima SC biosimilar begins Phase 3 trials in U.S.

Aug 01,2019
Celltrion will begin Phase 3 clinical trials for Remsima SC, a biosimilar, in the United States, the company said Wednesday.

It recently started to sign up patients who will take part in the tests at a clinical test center in Ohio. Earlier this year, Remsima SC received the nod from the U.S. Food and Drug Administration to be exempt from Phase 1 and 2 clinical trials.

Remsima SC is a subcutaneous version of Remsima, Celltrion’s biosimilar referencing the Remicade anti-inflammatory treatment. It treats various diseases, from arthritis and Adult Crohn’s disease. Whereas the original version is for intravenous injection by doctors, subcutaneous injections allow for patients to administer the drug at home.

By Song Kyoung-son