**”Goal to Complete Portfolio of 11 Products by Next Year”**
Celltrion announced on the 16th that it received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for the approval of four biosimilar products.
The products that received the approval recommendation are Abtozyme, Idengel, Stoboclo, and Ocenbelt. The original medicines for these biosimilars are Actemra, Eylea, and Prolia-Xgeva (Stoboclo·Ocenbelt), respectively.
Actemra is a treatment for autoimmune diseases characterized by its ability to reduce inflammation by inhibiting the interleukin (IL)-6 protein involved in causing inflammation in the body. Eylea is a treatment for ophthalmic conditions like wet age-related macular degeneration, working by binding to vascular endothelial growth factors to inhibit the formation of new blood vessels. Prolia is a treatment for osteoporosis, and its main component is also effective in preventing skeletal-related events in cancer patients with bone metastases, for which it is approved under the name Xgeva.
The CHMP is an organization that discusses the approval of medicines based on evaluation results and provides its opinion to the EMA. The EMA then gives its opinion on the marketability of the product, upon which the European Commission (EC) makes the final decision on the approval of the medicine.
Celltrion stated, “If we obtain final approval for these four biosimilars, we will have completed the goal of establishing a portfolio of 11 products by next year.”