Celltrion "4 Biosimilars Recommended for Approval in Europe"

"Goal to Complete Portfolio of 11 Product Types by Next Year"

Celltrion announced on the 16th that four biosimilars have received a recommendation for marketing authorization approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).

The products recommended for approval are Aptozma, Idenselt, Stoboclo, and Oscenbelt. The original drugs for these biosimilars are Actemra, Eylea, and Prolia-Xgeva (Stoboclo and Oscenbelt), respectively.

Actemra is characterized as a treatment for autoimmune diseases that reduces inflammation by inhibiting the interleukin (IL)-6 protein involved in triggering inflammation in the body. Eylea is an ophthalmic treatment for wet age-related macular degeneration and other eye diseases, which binds to vascular endothelial growth factor to inhibit neovascularization. Prolia is a treatment for osteoporosis, and its main ingredient is also effective in preventing bone metastasis complications in cancer patients; for this indication, it is approved under the name "Xgeva."

The CHMP is an agency that discusses approval decisions based on drug evaluation results and provides opinions to the EMA. Based on this, the EMA issues opinions on whether to market the product, and the European Commission (EC) makes the final decision on drug approval.

Celltrion stated, "If these four biosimilars obtain final approval, it will complete the targeted portfolio of 11 products by next year."

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