[Infostock Daily= Reporter Park Sang-In] Celltrion's world's first inflicsimab subcutaneous injection (SC) formulation Remsima SC has set a bridgehead for expanding its European market share.

Celltrion announced on the 29th that it received a recommendation for approval of approval for the application of Remsima SC for additional indications from the Drug Use Advisory Committee under the European Medicines Agency (EMA) on the 25th (local time).

CHMP is an organization that presents opinions on whether to approve EMA based on the results of scientific evaluation of medicines. CHMP's approval recommendation is actually interpreted as meaning European drug approval.

Generally, the final approval of the European Commission (EC) takes place within one to three months of the recommendation for approval of CHMP approval. As a result, Remsima SC is expected to be the first infliximab SC formulation to acquire all adult indications for existing inflicimab intravenous injections (IV) formulations.

The indications for approval include Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriasis and psoriasis in adults.

Celltrion plans to proceed with the approval process in 97 countries (including 31 European countries) around the world within the year based on the same clinical results when it obtains the approval in Europe. In addition, the US and Japan are also in the process of licensing new drugs with the aim of shortest approval.

Celltrion has completed patent applications for Remsima SC formulations and SC administration in more than 100 countries around the world, including the United States, Europe, Asia, Latin America, the Middle East, Africa and Oceania. If the patent is registered after examination by each country, the patent will be protected by 2037 and 2038 respectively.

This patent is a barrier patent designed to defend not only Remsima SC but also the entry of inflicsimab subcutaneous injection biosimilars into the market. Celltrion is expected to monopolize the inflicsimab subcutaneous injection market, which is protected for 20 years from the patent application date.

Reporter Park Sang-In si2020@infostock.co.kr

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