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.
In summary, 13 companies have biosimilar pembrolizumab clinical trials either recorded on the ClinicalTrials.gov registry or announced in press releases. Formycon’s FYB206 appears to be the front runner, having demonstrated pharmacokinetic bioequivalence with Keytruda® in its “Dahlia” study (reported in February 2026). Formycon’s US commercialisation partner, Zydus, has also expressed optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.
More detail is provided below:
- 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. On 25 February 2026, Formycon announced positive results from the study (“Dahlia”), with demonstration of bioequivalence of FYB206 and Keytruda®. Formycon had originally intended to conduct a parallel Ph 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 Ph 3 trial on the basis that the trial was not necessary to obtain US approval of FYB206. Formycon has entered into commercialisation agreements for FYB206 with Zydus (US and Canada), MS Pharma (MENA Region) and Lotus Pharmaceutical (parts of Asia Pacific). Zydus is optimistic about filing the first biosimilar pembrolizumab BLA in the US.
- Samsung Bioepis (SB27): On 5 May 2026, reports were published announcing positive preliminary Ph 1 data for Samsung Bioepis’ SB27 (pembrolizumab). However, those reports were subsequently withdrawn from a number of news sites. The Phase 1 study is expected to be completed by November 2026. A Ph 3 study to compare efficacy, safety, PK and immunogenicity between SB27 and Keytruda® in patients with metastatic nsNSCLC was initiated in April 2024. The study’s estimated primary completion date has been revised from September 2025 to March 2026, but no results have yet been reported.
- Bio-Thera (BAT3306): A Ph 1/3 study was 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. However, the study has been terminated due to “new regulatory developments” leading Bio-Thera to “conclude that a Phase 3 study is no longer necessary for the development and approval of BAT3306”. A Phase 1 study to compare the pharmacokinetics and safety of BAT3306 versus Keytruda® was completed in June 2024. In February 2026, Bio-Thera entered into a commercialisation and licence agreement with Avalon Pharma for BAT3306 in Saudi Arabia and MENA.
- 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 has completed recruitment and its estimated primary completion date has been revised from March 2026 to December 2026. A Ph 3 study was also 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 has completed recruitment and has an estimated primary completion in January 2028.
- 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 has completed recruiting and has an estimated primary completion date in June 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 recruiting with estimated primary completion in February 2027.
- Shanghai Henlius (HLX17): A Ph 1 study was initiated in September 2025, and is currently recruiting, to evaluate the similarity in PK profile, efficacy, safety and immunogenicity of HLX17 vs Keytruda® in patients with resected non-small cell lung cancer, melanoma or renal cell carcinoma (expected primary completion April 2027). A second study (integrated Ph 1/3) 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 has an estimated primary completion in April 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 February 2029.
- Qilu Pharmaceutical (QL2107): Ph 3 study initiated in January 2025 to compare the efficacy and safety of QL2107 vs Keytruda® in combination with chemotherapy in treating metastatic non-squamous non-small-cell lung cancer. The study is currently recruiting and has an estimated primary completion date of December 2026.
- R-Pharm (RPH-075): A Ph 3 study to compare the efficacy, safety and immunogenicity of PRH-075 with Keytruda® in patients with unresectable or metastatic skin melanoma. The study’s status is currently recorded as “unknown”. A Ph 1 study was initiated in March 2023 to compare the safety, immunogenicity and pharmacodynamics of PRH-075 with Keytruda® in patients with malignant neoplasms and also is recorded to have an “unknown” status.
- Biocad (BCD-201): Biocad initiated a Ph 1 study in 2021 to evaluate the pharmacokinetics and safety of BCD-201 and Keytruda® in patients with different advanced malignancies. The current status of the study is recorded as “unknown”. In November 2025, Biocad’s pembrolizumab biosimilar was reportedly approved in Vietnam.
- Enzene: Ph 3 clinical trial recommended in India in April 2026 to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of Enzene’s biosimilar pembrolizumab versus Keytruda® in combination with pemetrexed and platinum based chemotherapy in adult patients with metastatic non-small cell lung cancer.
In addition, Alvotech has confirmed that it has a pembrolizumab biosimilar in development, on which it is partnering with Dr Reddy’s, with expectations of filing a marketing authorisation application in 2028. Amneal also has a pembrolizumab biosimilar in early development.
Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).