Samsung Bioepis, a subsidiary of Samsung Epis Holdings, announced in a regulatory filing on the 30th that it has filed for product approval in the United States for 'SB27' (ingredient name: pembrolizumab), a biosimilar of Keytruda. The filing date was October 29, 2026, US local time, and the regulatory authority is the US Food and Drug Administration (FDA).

■ Application Filed for 18 Cancer Indications

The application covers a total of 18 indications, including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, esophageal cancer, cervical cancer, renal cell carcinoma, endometrial cancer, triple-negative breast cancer, and ovarian cancer.

■ Equivalence in Efficacy and Safety Demonstrated in Phase 3 Trial Involving 555 Patients

Samsung Bioepis conducted a randomized, double-blind, multi-center phase 3 clinical trial comparing the efficacy, safety, pharmacokinetics, and immunogenicity of SB27 and Keytruda in patients with metastatic non-squamous non-small cell lung cancer. The primary endpoint of the trial, which involved a total of 555 participants, was the objective response rate (ORR) at 24 weeks.

According to the company, the assessment of the objective response rate at 24 weeks showed that the 90% confidence interval fell within the pre-defined equivalence margin, demonstrating efficacy equivalence between SB27 and Keytruda. In the safety evaluation, the incidence and severity distribution of treatment-emergent adverse events (TEAEs) were similar between the two treatment groups, and the incidence rates of other safety assessment items, including serious adverse events, were also found to be similar between the groups.

■ BLA Completed… Plans to File for Approval by Country

Samsung Bioepis stated that, based on the clinical data it has secured, it has completed a Biologics License Application (BLA) with the US FDA and plans to continue filing for approvals in individual countries going forward. The company explained that it expects the indications covered by this application to provide treatment opportunities to more patients in the future.

However, the company noted that this product approval application does not guarantee final approval. It added that the review process may yield results that fall short of expectations, and that it may therefore modify or abandon its commercialization plans.

Meanwhile, Samsung Bioepis is a subsidiary of Samsung Epis Holdings, and as of the end of 2025, its total assets accounted for 97.42% of Samsung Epis Holdings' total assets based on separate financial statements.