Celltrion's Remsima SC Recommended for Additional Indication Approval in Europe

[Asia Economy Reporter Cho Hyun-ui] Celltrion's infliximab subcutaneous injection formulation 'RemsimaSC,' the world's first developed, is expected to receive marketing authorization in Europe for the treatment of inflammatory bowel disease. Accordingly, RemsimaSC is anticipated to become the first infliximab SC formulation to obtain all adult indications of the infliximab intravenous (IV) formulation, from rheumatoid arthritis to adult inflammatory bowel disease.

Celltrion announced on the 29th that RemsimaSC received a 'recommendation for approval' opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) on the 25th (local time) regarding the application for additional indications.

The CHMP's recommendation for approval is interpreted as effectively meaning European drug approval. Generally, the European Commission's (EC) final approval is granted within 1 to 3 months after the CHMP's recommendation for approval. To expedite the approval of RemsimaSC, Celltrion has pursued a strategy of first obtaining EMA approval for the rheumatoid arthritis indication in November last year, followed by expansion to other major indications such as inflammatory bowel disease.

With this approval recommendation, RemsimaSC now covers adult inflammatory bowel diseases including rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

After final approval from the EC, RemsimaSC is expected to be marketed as the first complete infliximab SC formulation in 31 European countries. Additionally, approval procedures will proceed within this year for 97 countries worldwide (including 31 European countries). The new drug approval process is also underway in the United States and Japan, aiming for the shortest possible approval period.

RemsimaSC, the first infliximab SC formulation drug, has completed patent applications for its formulation and administration method in over 100 countries worldwide. Once patents are registered by country, patent protection will be granted until 2037 and 2038, respectively.

A Celltrion official stated, "As the additional indication approval for RemsimaSC becomes visible, we expect to further strengthen our position in the global autoimmune disease treatment market. Infliximab, the main ingredient of RemsimaSC, is highly regarded by specialists in the field of inflammatory bowel disease, so a remarkable market share is anticipated in the future."

This content was produced with the assistance of AI translation services.