Samsung Bioepis Applies for Domestic Approval of Keytruda Biosimilar

First Domestic Approval Application Filed
Equivalence Demonstrated with Original Drug in Global Phase 1 and 3 Trials
Covers 16 Indications Including Melanoma, Lung Cancer, and Head and Neck Cancer

Samsung Bioepis has applied for domestic approval of a biosimilar to the global blockbuster immuno-oncology drug "Keytruda."

Exterior view of Samsung Bioepis building. Samsung Bioepis

On August 10, Samsung Bioepis announced that it had submitted an application to the Ministry of Food and Drug Safety for the marketing authorization of its Keytruda biosimilar candidate, SB27 (ingredient name: pembrolizumab). This marks the first time an application for marketing authorization of a Keytruda biosimilar has been filed in Korea.

Keytruda is an immune checkpoint inhibitor developed by Merck & Co. (MSD) that achieved global sales of approximately USD 31.7 billion (about 46 trillion won) last year. By inhibiting PD-1, which plays a role in cancer cells' immune evasion, it restores the anti-cancer function of immune cells and is used in various cancer types. The current application covers a total of 16 indications, including melanoma, non-small cell lung cancer, and head and neck cancer.

Since 2024, Samsung Bioepis has conducted global clinical trials to confirm the equivalence between SB27 and the original medication. The Phase 1 trial was conducted in four countries with 163 participants, while the Phase 3 trial was conducted in 14 countries with 555 participants.

Donghun Shin, Head of Clinical Medical at Samsung Bioepis, said, "During the review process for marketing authorization, we will thoroughly present the R&D results of SB27 and carry out all necessary procedures seamlessly so that immuno-oncology treatment options can be promptly provided to domestic patients."

Samsung Bioepis currently markets 11 types of biosimilars in Korea, including treatments for autoimmune, oncological, ophthalmic, and rare diseases. The company is also developing seven pipeline biosimilars, including SB27.

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