With a number of biosimilars to MSD’s Keytruda® (pembrolizumab) currently in clinical trials, we provide the following update on those trials and their status, based on previous reports and the information available to date in the clinicaltrials.gov registry:
- Samsung Bioepis (SB27): Ph 3 study to compare efficacy, safety, PK and immunogenicity between SB27 and Keytruda® in patients metastatic nsNSCLC initiated in April 2024. The study is currently recruiting with estimated primary completion in September 2025.
- Amgen (ABP 234): Ph 3 study in nsNSCLC initiated May 2024 to compare PK between ABP 234 and Keytruda® in patients with early-stage nsNSCLC as adjuvant treatment following resection and platinum-based chemotherapy. The study is currently recruiting, with estimated primary completion in March 2026. Ph 3 study commenced in September 2024 to compare the efficacy, PK, safety and immunogenicity between ABP 234 and Keytruda® in patients with advanced or metastatic nsNSCLC. The study is currently recruiting, with estimated primary completion in February 2028.
- Formycon (FYB206): Integrated Ph1/3 study commenced in June 2024 to demonstrate PK similarity of FYB206 with Keytruda® in patients with Stage IIB/IIC or Stage III melanoma. On 10 July 2025, Formycon announced that it had completed patient enrolment. Formycon expects results to be available in Q1 2026. Formycon had originally intended to conduct a parallel Phase 3 trial to compare the safety and efficacy of FYB206 with Keytruda® in NSCLC. However, in February 2025, Formycon announced the premature termination of the Phase 3 trial on the basis that the trial was not necessary to obtain US approval of FYB206.
- mAbxience (MB12): Ph 3 study to compare the PK, efficacy, safety and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic nsNSCLC. The study commenced in December 2024 and is currently recruiting, with estimated primary completion in June 2026.
- Sandoz (GME751): Ph 1 study commenced in May 2024 to compare PK of GME751 and Keytruda® in patients with stage II and III melanoma requiring adjuvant treatment with pembrolizumab. The study is currently recruiting with estimated primary completion in July 2026. In April 2025, Sandoz announced it has “minimised” its Ph 3 trial in untreated metastatic nsNSCLC due to streamlining of FDA study requirements.
- Celltrion (CT-P51): Ph 3 trial plan approved by FDA in August 2024 with study initiated in January 2025 to compare efficacy and safety of CT-P51 and Keytruda® in combination with platinum pemetrexed chemotherapy in patients with previously untreated metastatic nsNSCLC. The study is currently recruiting with estimated primary completion in February 2027.
- Shanghai Henlius (HLX17): Integrated Ph 1/3 study initiated in April 2025 to evaluate the efficacy, safety, PK profile and immunogenicity of HLX17 vs Keytruda® in the first-line treatment of advanced nsNSCLC. The study is not yet recruiting, with estimated primary completion in April 2027.
- Bio-Thera (BAT3306): Ph 1/3 study commenced in July 2024 to evaluate the PK, efficacy and safety of BAT3306 plus chemotherapy versus Keytruda® plus chemotherapy in patients with stage IV nsNSCLC. The study is currently recruiting with estimated primary completion in July 2027.
- BioNTech (BNT327): Phase 2/3, Master Protocol for a Global Trial of BNT327 in combination with chemotherapy and other investigational agents in first-line NSCLC, initiated in January 2025. The study is currently recruiting, with estimated primary completion in December 2029.