Samsung Bioepis, a subsidiary of Samsung Epis Holdings, has submitted a domestic product license application to the Ministry of Food and Drug Safety (MFDS) for 'SB27,' a biosimilar of the global blockbuster anti-cancer drug 'Keytruda' (ingredient name: pembrolizumab).

In a regulatory filing on the 10th, Samsung Epis Holdings announced that Samsung Bioepis officially submitted the product license application for SB27 to the MFDS on the 7th.

• A total of 15 indications have been submitted for approval, as follows:
• Melanoma, non-small cell lung cancer, malignant pleural mesothelioma, head and neck cancer
• Classical Hodgkin lymphoma, urothelial carcinoma, gastric cancer, esophageal cancer
• Renal cell carcinoma, endometrial cancer, high-frequency microsatellite instability (MSI-H) cancer, and colorectal cancer
• Triple-negative breast cancer, cervical cancer, biliary tract cancer, hepatocellular carcinoma

• *Phase 3 Clinical Trial Results (Based on 555 Patients)**
• The Phase 3 clinical trial for SB27 was conducted on 555 patients with metastatic non-squamous non-small cell lung cancer. It was a randomized, double-blind, multi-center clinical trial evaluating efficacy, safety, pharmacokinetics, and immunogenicity compared to the reference product, Keytruda.
• Efficacy: The 90% confidence interval of the objective response rate (ORR) at week 24, the primary endpoint, fell within the pre-defined equivalence criteria range, demonstrating efficacy equivalence between SB27 and Keytruda.
• Safety: The incidence and distribution of treatment-emergent adverse events (TEAEs) after overall treatment were similar between groups, and the incidence rates of other items, including serious TEAEs, were also comparable between the two groups.

Future Plans and Investment Precautions Having completed the domestic approval application based on the acquired clinical data, Samsung Bioepis plans to continue applying for approvals by country and target the global market going forward.

However, the company clarified that submitting a product license application does not guarantee final approval from regulatory authorities. It specified as an investment precaution that if the review process yields results that do not meet expectations, there is a possibility that commercialization plans may be altered or entirely abandoned.