SB27 demonstrates equivalence to original in Phase 1 and Phase 3 trials; 18 indications including lung cancer targeted

Samsung Bioepis [Samsung Bioepis]
Samsung Bioepis [Samsung Bioepis]

Samsung Bioepis has filed for US regulatory approval of its biosimilar candidate for Keytruda, the world's top-selling cancer immunotherapy drug.

Samsung Bioepis said Friday it submitted a biologics license application to the US Food and Drug Administration for SB27, a biosimilar of Keytruda with the active ingredient pembrolizumab.

The filing follows Samsung Bioepis' submission in August to South Korea's Ministry of Food and Drug Safety — the first domestic application for a Keytruda biosimilar — and marks the company's formal push into the world's largest pharmaceutical market.

Keytruda, developed by US drugmaker MSD, is the world's best-selling blockbuster drug, generating about 46 trillion won ($34.4 billion) in global sales last year.

The drug works by binding to the PD-1 receptor on immune cells to block cancer cells' immune-evasion mechanism, prompting the patient's immune system to attack the cancer.

The BLA covers 18 indications, including melanoma, non-small cell lung cancer and head and neck cancer.

Samsung Bioepis confirmed SB27's equivalence to the original drug in efficacy and safety through a Phase 1 trial involving 163 patients across four countries and a Phase 3 trial involving 555 patients across 14 countries, both conducted since 2024. All related global clinical trials are expected to be completed by year-end.

With Keytruda's patent expiration approaching — the drug commands a single-product market worth more than 40 trillion won annually — Samsung Bioepis has moved proactively through both domestic and US approval processes, positioning itself as a leader within the global first-mover group racing to commercialize a biosimilar.

"We will again demonstrate our research and development capabilities throughout the FDA review process for SB27," said Shin Dong-hoon, executive vice president and head of clinical medicine at Samsung Bioepis. "We will continue working to expand treatment options and improve access for patients in the field of cancer immunotherapy through biosimilars."


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