Samsung Bioepis Receives European Marketing Authorization for Avastin Biosimilar

[Asia Economy Reporter Cho Hyun-ui] Samsung Bioepis announced on the 21st that it has received marketing authorization from the European Commission (EC) for the anticancer drug Avensio (SB8). Avensio is a biosimilar of Avastin, a colorectal and lung cancer treatment developed by the multinational pharmaceutical company Roche.

Samsung Bioepis obtained approval just two months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in June. This marks the first time a domestic company has received marketing authorization for a biosimilar of Avastin.

Avastin is a blockbuster biopharmaceutical with global sales reaching approximately 8.5 trillion KRW last year. Of this, sales in Europe accounted for about 2.2 trillion KRW, representing roughly 26% of the total.

With this marketing authorization, Samsung Bioepis has secured approval for all five autoimmune and oncology treatment pipelines it disclosed at its founding in 2012. It is the company with the most antibody biosimilar products independently developed and authorized in the European market.

Go Han-seung, President of Samsung Bioepis, stated, "By securing the fifth biosimilar in the global market, we have laid the foundation to become a leading company in the industry," adding, "Through Avensio, we will expand opportunities for cancer patients to receive treatment with high-quality biopharmaceuticals."

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