Samsung Bioepis Files Korea’s First Keytruda Biosimilar Application
Domestic approval procedures have begun in earnest as companies move to gain an early foothold in the biosimilar market for Keytruda, the world’s biggest blockbuster drug with annual sales of 46 trillion won, or approximately 32.43 billion.Samsung Bioepis said on Aug. 10 that it had filed an applica
Samsung Bioepis has initiated the domestic approval process for its Keytruda biosimilar, "SB27," marking the first instance in South Korea to enter the commercialization stage. The biosimilar, developed to target immuno-oncology treatments, is manufactured by U.S. company Merck Sharp & Dohme. Keytruda, a world-leading blockbuster drug with annual sales of about 46 trillion won ($32.43 billion), has been proven to suppress the immune evasion mechanism of cancer cells, thereby aiding the body's immune system in directly attacking cancer cells.
Samsung Bioepis has conducted extensive clinical trials, including Phase 1 and Phase 3 trials, to demonstrate the pharmacokinetic equivalence, efficacy, and safety of SB27. The company's application includes indications for 16 diseases, such as melanoma, non-small cell lung cancer, and head and neck cancer. Samsung Bioepis has already secured 11 biosimilars in South Korea, with seven more products in their pipeline, positioning itself strongly in the biopharmaceutical market.
This filing demonstrates Samsung Bioepis' ambition to provide domestic patients with immunotherapy treatment options as swiftly as possible, as they aim to compete with global pharmaceutical companies racing to commercialize Keytruda biosimilars.
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