Samsung Bioepis Seeks Approval for Groundbreaking Keytruda Biosimilar

Samsung Bioepis has submitted a marketing authorization application to South Korea's Ministry of Food and Drug Safety for its Keytruda biosimilar candidate, SB27. This marks the first Keytruda biosimilar marketing authorization application ever submitted in South Korea.

Keytruda is an immunotherapy drug developed by Merck (MSD) that works by binding to the PD-1 immune checkpoint receptor, inhibiting cancer cells' immune evasion and helping the body's immune system attack cancer cells. The company confirmed the equivalence of SB27 to the originator drug through large-scale global clinical trials.

The application was filed on August 7, with a total of 16 indications sought for approval, including melanoma, non-small cell lung cancer, and head and neck cancer. Under South Korea's streamlined review policy for biosimilars, SB27 could receive marketing approval as early as next year.

Samsung Bioepis already markets 11 biosimilars in South Korea, covering autoimmune diseases, oncology, ophthalmology, and rare diseases. The company is developing seven follow-on biosimilar pipelines, including SB27, which is a candidate developed independently by Samsung Bioepis without a separate partner agreement.