Remsima SC gets initial nod for more uses in Europe

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Remsima SC gets initial nod for more uses in Europe

Remsima SC, Celltrion Healthcare’s self-applicable biosimilar of infliximab, will likely be available for patients in Europe suffering from ailments beyond what the drug was originally approved to treat.  

According to the Korean company on Monday, the Committee for Medicinal Products for Human Use (CHMP) recommended the European Medicines Agency (EMA) expand the existing authorization for Remsima SC to include five additional indications, including inflammatory bowel disease (IBD).  

CHMP is a committee under the EMA that publishes scientific opinions on questions concerning human medicines. Most CHMP recommendations submitted receive final marketing approvals from the EMA within one to three months' time, the Korean company explained.  

Remsima SC received a marketing authorization from the EMA November last year as a treatment for rheumatoid arthritis. Another approval allowing it to be used on inflammatory bowel disease would be meaningful for the product in that it opens up a new market worth $14 billion globally, based on 2019 revenue.  

Celltrion’s Remsima is the biosimilar of infliximab, which was marketed under the name Remicade by Johnson & Johnson. An autoimmune disease treatment, infliximab is used for multiple diseases. Patients with rheumatoid arthritis were the largest market, and those of inflammatory bowel disease followed second.  

Remsima SC is the subcutaneous formulation of the biosimilar, meaning it can be applied by the patient at home instead of going to the hospital for every shot. At the moment, Remsima SC is the only subcutaneous infliximab approved for sale in Europe. Remsima’s intravenous formulation, applied at hospitals, received the nod to be sold in the market earlier in 2013.  

In order to start sales in Europe faster, Celltrion had received a marketing approval for the product to treat rheumatoid arthritis first in November, as clinical trials for that use are relatively fast. A separate round of trials to test Remsima SC’s effectiveness in treating the five other diseases were finished last year, which resulted in CHMP’s latest recommendation.  

The final EMA approval would make Remsima SC the first subcutaneous infliximab biosimilar that covers all of the original medicine’s indications.  

“Given the current Covid-19 pandemic, this is timely and welcome news, particularly for immunocompromised patients who must take extra precaution and only visit hospitals when absolutely necessary,” said Prof. Walter Reinisch of gastroenterology and hepatology at Medical University of Vienna, and director of the clinical IBD study group.

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