Samsung Bioepis Reports Positive Phase 1 and Phase 3 Results for SB27, Its Proposed Pembrolizumab Biosimilar
Samsung Bioepis Co., Ltd. has announced encouraging topline results from its Phase 1 and Phase 3 clinical development program for SB27, the company’s proposed biosimilar to Keytruda® (pembrolizumab). Both studies successfully achieved their primary endpoints, marking a significant milestone in the development of one of the company’s latest oncology biosimilar candidates and reinforcing its strategy to expand access to high-quality biologic therapies for cancer patients worldwide.
The successful completion of these key clinical milestones brings Samsung Bioepis closer to advancing SB27 toward regulatory submissions and potential commercialization. The company stated that both clinical studies remain on schedule and are expected to be completed later this year, supporting its ongoing commitment to strengthening its oncology biosimilar portfolio.
Positive Clinical Results Reinforce Samsung Bioepis’ Biosimilar Expertise
Samsung Bioepis highlighted that the positive preliminary findings demonstrate the scientific rigor and clinical capabilities that have enabled the company to become one of the leading developers of biosimilar medicines globally.
The company has built an extensive portfolio of biosimilars across multiple therapeutic areas, including oncology, immunology, ophthalmology, endocrinology, and hematology. The successful development of a pembrolizumab biosimilar represents another important step as immune checkpoint inhibitors continue to transform modern cancer treatment.
Commenting on the announcement, Donghoon Shin, Executive Vice President and Head of the Clinical Sciences Division at Samsung Bioepis, said the company is pleased with the preliminary outcomes from both studies evaluating SB27.
He noted that achieving positive topline results in both Phase 1 and Phase 3 clinical trials highlights Samsung Bioepis’ scientific expertise and leadership in biosimilar development. According to Shin, the company remains on track to complete both studies during the current year and continues to leverage its robust quality management systems to expand its biosimilar pipeline and improve patient access to important biologic medicines for individuals with unmet medical needs.
Pembrolizumab Has Become a Cornerstone of Modern Cancer Treatment
Pembrolizumab is among the world’s most widely used immuno-oncology therapies.
Marketed as Keytruda, the medicine is a humanized monoclonal antibody that functions as an immune checkpoint inhibitor by targeting the programmed cell death protein-1 (PD-1) receptor found on T lymphocytes.
By blocking PD-1, pembrolizumab enables the body’s immune system to recognize and attack cancer cells more effectively.
Since its initial approval, Keytruda has become a standard treatment across numerous cancer types, including:
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell carcinoma (HNSCC)
- Urothelial carcinoma
- Renal cell carcinoma
- Triple-negative breast cancer
- Classical Hodgkin lymphoma
- Various gastrointestinal cancers
Because of its broad range of approved indications and expanding use in combination therapies, pembrolizumab has become one of the highest-selling oncology biologics globally.
The development of biosimilars such as SB27 has the potential to improve treatment accessibility while helping healthcare systems manage rising oncology costs.
Phase 1 Study Demonstrated Pharmacokinetic Bioequivalence
One of the two pivotal studies supporting SB27 was a randomized, double-blind, three-arm, parallel-group, multicenter Phase 1 clinical trial designed to compare the pharmacokinetic characteristics of SB27 with those of both European Union-sourced and United States-sourced Keytruda.
The study enrolled patients with Stage II or Stage IIIA non-small cell lung cancer who had previously undergone complete surgical resection followed by adjuvant platinum-based chemotherapy.
A total of 163 participants were randomly assigned to receive one of three treatment groups:
- SB27
- EU-sourced Keytruda
- US-sourced Keytruda
Patients received treatment every three weeks for up to 51 weeks while investigators collected serial blood samples to evaluate pharmacokinetic parameters.
The primary objective of the study was to establish pharmacokinetic bioequivalence by comparing systemic drug exposure between SB27 and the reference medicines.
According to the preliminary analysis, SB27 successfully met the predefined equivalence criteria for Area Under the Curve (AUC), one of the principal pharmacokinetic measurements used to evaluate drug exposure.
In addition to pharmacokinetics, investigators also assessed efficacy, safety, and immunogenicity throughout the study.
The successful achievement of pharmacokinetic equivalence represents an essential requirement in biosimilar development and provides important evidence that SB27 behaves similarly to the reference pembrolizumab products within the body.
Phase 3 Trial Confirmed Comparable Clinical Effectiveness
Samsung Bioepis also announced positive topline findings from its larger Phase 3 confirmatory study.
The randomized, double-blind, parallel-group, multicenter clinical trial evaluated the efficacy, safety, pharmacokinetics, and immunogenicity of SB27 compared with Keytruda in patients with metastatic non-squamous non-small cell lung cancer.
The study enrolled 555 participants, who were randomly assigned to receive either SB27 or reference Keytruda.
Both treatment groups also received standard chemotherapy consisting of:
- Pemetrexed
- Carboplatin
Treatment was administered every three weeks for as long as 48 weeks.
The primary endpoint of the study was the Objective Response Rate (ORR) measured at Week 24.
According to the preliminary topline analysis, SB27 demonstrated an objective response rate equivalent to that observed with the reference product.
Specifically, the 90% confidence interval for the ORR ratio between SB27 and Keytruda ranged from 0.737 to 1.071.
This interval fell entirely within the predefined equivalence margin of 0.712 to 1.405, thereby satisfying the statistical criteria required to demonstrate therapeutic equivalence between the biosimilar candidate and the originator medicine.
Comparable Safety and Immunogenicity
Beyond efficacy, Samsung Bioepis reported that SB27 exhibited safety findings consistent with those observed for Keytruda.
Investigators found that:
- Overall safety profiles were comparable between treatment groups.
- Pharmacokinetic characteristics remained consistent.
- Immunogenicity results showed no clinically meaningful differences.
These findings further strengthen the totality of evidence supporting SB27 as a potential biosimilar.
Regulatory agencies typically evaluate biosimilars using a comprehensive approach that considers analytical similarity, pharmacokinetic equivalence, clinical efficacy, safety, and immunogenicity rather than relying solely on one clinical endpoint.
The positive outcomes across these multiple domains represent important components of the overall biosimilar evidence package.
Expanding Access to Cancer Immunotherapy
The development of biosimilars has become an increasingly important strategy for improving global access to biologic medicines.
While immune checkpoint inhibitors such as pembrolizumab have significantly improved survival outcomes for many cancer patients, their high cost can limit availability in some healthcare systems.
Biosimilars are designed to provide highly similar alternatives to approved biologic medicines after patent exclusivity expires, helping increase competition and potentially reduce treatment costs without compromising quality, safety, or efficacy.
For healthcare providers and patients, additional biosimilar options may improve treatment accessibility while supporting the long-term sustainability of oncology care.
Strengthening Samsung Bioepis’ Oncology Portfolio
The positive SB27 data further expand Samsung Bioepis’ growing presence in oncology biosimilars.
Over the past decade, the company has established itself as one of the world’s leading biosimilar developers, successfully introducing multiple products across several therapeutic categories.
The advancement of SB27 reflects Samsung Bioepis’ continued investment in complex biologic development and its strategy to address growing demand for affordable oncology therapies.
With both pivotal studies successfully meeting their primary endpoints, the company plans to complete the Phase 1 and Phase 3 programs later this year before proceeding with regulatory submissions in major global markets.
The positive topline results from both the Phase 1 pharmacokinetic study and the Phase 3 efficacy trial represent an important milestone for Samsung Bioepis and its proposed pembrolizumab biosimilar, SB27. Demonstrating pharmacokinetic bioequivalence, equivalent objective response rates, and comparable safety and immunogenicity profiles provides strong clinical evidence supporting the biosimilar candidate.
As Samsung Bioepis prepares to finalize both studies and advance toward regulatory review, SB27 has the potential to become an important new treatment option for patients with multiple types of cancer. If approved, the biosimilar could contribute to broader global access to pembrolizumab therapy while helping healthcare systems expand the availability of life-saving immuno-oncology treatments.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology and neurology.
