Samsung Bioepis Biosimilar Matches Keytruda in Trials
The candidate SB27 demonstrates pharmacokinetic equivalence, marking a new step toward competition in the cancer drug market.
Updated on Oct. 27, 2026 in Biotech
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Samsung Bioepis has confirmed that its biosimilar candidate, SB27, demonstrates pharmacokinetic equivalence to the oncology drug Keytruda. These findings, based on a Phase 1 clinical trial, currently exist at the research stage.
Why it matters
As Keytruda generated $31.7 billion in global sales in 2025, the development of biosimilar alternatives like SB27 represents a significant step toward increasing market competition for high-cost immunotherapy treatments.
The study measured pharmacokinetic equivalence through blood concentration analysis using the area under the curve (AUC). This performance parameter showed that SB27 functions similarly to the original drug in terms of its presence in the body.
The players
Samsung Bioepis
A biopharmaceutical subsidiary of Samsung specializing in the development and manufacturing of biosimilar medicines.
MSD
The global pharmaceutical company that manufactures Keytruda, a leading immune checkpoint inhibitor used in cancer therapy.
The details
In the trial, researchers divided 163 participants with non-small cell lung cancer into groups receiving either SB27 or the approved Keytruda drug. The primary analysis tracked the area under the curve, a pharmacokinetic metric that quantifies total drug exposure in the bloodstream over time. Clinical observations indicated that both the efficacy and safety profiles of the biosimilar remained consistent with the original medication.
Timeline
2024: Samsung Bioepis initiated Phase 1 clinical trials for SB27.
2025: Keytruda reached $31.7 billion in global sales.
October 23-27, 2026: Results were presented at the European Society for Medical Oncology in Madrid.
The Tech Race
This research follows a broader industry trend of developers creating biosimilar competitors for high-revenue biologics like Keytruda. The entry of SB27 into the pipeline signals a transition toward increased generic competition for complex cancer therapies.
Patients and healthcare providers should note that SB27 is currently in clinical research and not yet available for clinical use. Future availability and pricing will depend on successful completion of further trials and subsequent regulatory approval.
The takeaway
The clinical trial results establish a path for SB27 as a potential competitor in the multi-billion dollar immunotherapy market. Stakeholders should monitor Samsung Bioepis for updates regarding the initiation and results of Phase 3 trials.
Further reading
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