Samsung Bioepis Reports Phase 3 Keytruda Biosimilar Data
Phase 3 results for the proposed pembrolizumab biosimilar SB27 were presented at the SITC 2026 annual meeting.
Updated on Nov. 6, 2026 in Cancer
Samsung Bioepis announced on November 6 Phase 3 findings for SB27, a proposed biosimilar to Keytruda (pembrolizumab). The trial showed a 34.6% objective response rate at Week 24 for SB27 versus 37.9% for reference pembrolizumab, with a confidence interval within the pre-defined equivalence margin.
Why it matters
Biosimilars that demonstrate equivalence to reference immunotherapies could broaden patient access to PD-1 inhibitor treatments for lung cancer. The findings add to the evidence base evaluators will consider for SB27's regulatory pathway.
The Phase 3 trial randomized 555 patients with metastatic non-squamous NSCLC 1:1, showing a Week 24 ORR of 34.6% for SB27 versus 37.9% for reference pembrolizumab, with the 90% confidence interval for the ratio (0.737 to 1.071) falling entirely within the pre-defined equivalence margin of 0.712 to 1.405. Longer-term survival and regulatory outcomes have not been reported in the presented findings.
The players
Samsung Bioepis
Samsung Bioepis is the biosimilar development arm of Samsung, focused on developing and commercializing biosimilar versions of biologic medicines.
Keytruda (pembrolizumab)
Keytruda is Merck's PD-1 inhibitor immunotherapy, a humanized monoclonal antibody widely used across multiple cancer types.
The details
Participants received 200 mg of pembrolizumab intravenously every three weeks alongside pemetrexed and carboplatin for the first four cycles. The study also assessed safety, pharmacokinetics and immunogenicity, which Samsung Bioepis reported were comparable to Keytruda.
Timeline
November 4 to 8, 2026: SITC Annual Meeting held in Phoenix, Arizona.
November 6, 2026: Samsung Bioepis announced the SB27 Phase 3 findings.
Big Picture
The SB27 trial extends the effort to develop biosimilars of Keytruda, the PD-1 inhibitor whose patent-protected status has made it a central target for lower-cost alternatives. The Phase 3 equivalence data reported here are the type of evidence biosimilar developers must present to reach regulators.
For patients with metastatic non-squamous lung cancer, biosimilar versions of pembrolizumab could eventually offer a lower-cost option if approved. The SB27 data suggest response rates close to reference Keytruda, though approval and availability have not yet been established.
The takeaway
Biosimilar equivalence trials measure whether response rates stay within a pre-set margin of the original drug, not whether they are identical. Readers should watch for regulatory decisions and longer-term survival data before drawing conclusions about SB27's clinical role.
Further reading
For more on treatment research, explore Cancer coverage on Wisevoter.
Source note: This article includes information reported by Business Korea.
