Celltrion has received the green light for the European market sales approval of four biosimilars.
Celltrion noted on the 16th that it received a recommendation for European market authorization approval for four biosimilars from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The CHMP's recommendation plays a decisive role in the final approval by the European Commission (EC). As such, the market interprets this as virtually implying European drug approval.
The medications that received the approval recommendation this time include ▲ the autoimmune disease treatment Actemra biosimilar AVTOZMA, ▲ the ophthalmic disease treatment Eylea biosimilar EYDENZELT, and ▲ the osteoporosis and cancer bone metastasis complication treatment Prolia-Xgeva biosimilar STOBOCLO and OSENVELT, making a total of four. These were proven to be equivalent and similar to the original medications through previous global Phase 3 clinical trials.
If these four biosimilars obtain final approval, Celltrion will achieve its earlier goal of establishing an '11-product portfolio by 2025' ahead of schedule. Celltrion expects that while its product range in the area of autoimmune diseases will deepen, expansion into new treatment areas such as bone and ophthalmic diseases will further increase sales and diversify its revenue sources. The company stated, 'The potential global market size for these 11 products is approximately 135 trillion won,' adding, 'Based on the strengthened product lineup, our position and negotiating power in the global market will be significantly enhanced.'
A company official remarked, 'It is rare for the CHMP to simultaneously recommend approval for four products from a single corporation,' adding, 'This has served as an opportunity to once again demonstrate Celltrion's technological capabilities and development competencies to the world.' He said, 'We will focus on the remaining approval processes and commercialization.'
Meanwhile, Celltrion aims to strengthen its dominance in the global market by establishing 22 product lines by 2030.