Samsung Bioepis announced on Monday that its biosimilar to Keytruda (pembrolizumab) has demonstrated equivalence in primary endpoints through analysis of global Phase 1 and Phase 3 clinical trial data.

Keytruda, the original drug developed by pharmaceutical giant MSD, is an immunotherapy used to treat various cancers including non-small cell lung cancer, melanoma, and head and neck cancers. It was the top-selling pharmaceutical product globally last year, with sales reaching approximately 46 trillion KRW (about 29.7 billion USD).

Since 2024, Samsung Bioepis has been conducting global Phase 1 and Phase 3 trials on non-small cell lung cancer patients to compare SB27 with the original drug in terms of pharmacokinetics, efficacy, safety, and immunogenicity.

In the Phase 1 trial, which involved 163 patients across four countries including South Korea, the company measured the area under the concentration-time curve (AUC) to analyze pharmacokinetics. The results met pre-established criteria, confirming pharmacokinetic equivalence to the original drug.

AUC is a pharmacokinetic parameter that indicates the extent of drug exposure in the body over time. In biosimilar development, it's used to assess equivalence to the reference product.

The Phase 3 trial, conducted with 555 patients across 14 countries, used objective response rate (ORR) as the primary endpoint. ORR measures the percentage of patients whose tumors shrink by a certain amount after 24 weeks of treatment. Results showed that SB27's efficacy was equivalent to the original drug. Safety and immunogenicity profiles were also similar.

Dr. Shin Dong-hoon, Head of Clinical Medicine at Samsung Bioepis, stated that demonstrating SB27's equivalence to the original drug is a significant milestone that showcases the global biosimilar development capabilities. It remains committed to improving patient access to immunotherapy treatments through the biosimilars, underpinned by the stringent quality control systems.

Samsung Bioepis announced on Monday that its biosimilar to Keytruda (pembrolizumab) has de …

Unlocking Cancer Treatment: Samsung Bioepis Achieves Keytruda Biosimilar Equivalence in Global Trials