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  However, those reports were subsequently withdrawn from a number of news sites.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).

On 10 May 2026, Shanghai Henlius Biotech announced that the European Commission (EC) has approved two new indications for Hetronifly® (serplulimab) including combination use for (a) certain metastatic oesophageal squamous cell carcinomas; and (b) certain non-squamous non-small cell lung carcinomas.

This follows positive opinions for these indications from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in March 2026.

Henlius’ Hetronifly® is the first and only anti-PD-1 mAb approved in the EU for extensive-stage small cell lung cancer (ES-SCLC).  Hetronifly® received a positive opinion from the European Medicines Agency’s CHMP for ES-SCLC in September 2024.  In February 2025, it was approved by the EC for use in combination with carboplatin and etoposide as a first-line treatment for adult patients with ES-SCLC.  It has since been approved in other countries for this indication, including the UK and India (June 2025).

Henlius’ serplulimab received its first approval from China’s National Medical Products Administration (NMPA) in November 2022, for the first-line treatment (in combination with carboplatin and paclitaxel) of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC).  It has also been approved in China for ES-SCLC, ESCC and nsqNSCL.  Henlius launched serplulimab as Hansizhuang® in certain Asian countries, including China, in August 2024.

Shanghai Henlius is pursuing regulatory approval of serplulimab for the perioperative treatment of gastric cancer.  In December 2025, its New Drug Application for Hansizhuang®, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant treatment after surgery, for gastric cancer was accepted by China’s National Medical Products Administration (NMPA) and granted Priority Review.

On 10 May 2026, Shanghai Henlius Biotech announced that the FDA has approved an Investigational New Drug (IND) application for a Phase 1 clinical trial of HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab), for the treatment of metastatic colorectal cancer (mCRC).

This follows approval of Henlius’ IND application for HLX05-N by China’s National Medical Products Administration in April 2026 for the same indication.

Cetuximab biosimilars have been approved and launched in India (Alkem’s Cetuxa™ approved January 2023, launched May 2023), China (Simcere Zaiming/Mabpharm’s Enlituo® (cetuximab beta) approved June 2024) and Russia (R-Pharm’s Arcetux™ approved February 2026).

On 7 May 2026, Daiichi Sankyo announced that AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) received approval from Korea’s Ministry of Food and Drug Safety on 30 April 2026 for the treatment of HER-2 positive metastatic breast cancer and gastric cancer.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights.  Daiichi Sankyo is solely responsible for manufacturing and supply.

In January 2026, Samsung Epis Holdings announced that a trastuzumab deruxtecan biosimilar was added to Samsung Bioepis’ pipeline, with the biosimilar in the early development stage in preparation for preclinical trials.

On 5 May 2026, Reuters reported that, from 1 July 2026, CVS Health will preference lower-cost, interchangeable biosimilars over Johnson & Johnson’s (J&J) Stelara® (ustekinumab) in ‌its most common drug lists.  CVS Health’s pharmacy benefit management unit, Caremark, will transition to biosimilar versions of Stelara®, such as Sandoz’s Pyzchiva® and Biocon Biologics’ Yesintek™, with most ⁠members paying $0 out-of-pocket for their therapy.

Sandoz’s Pyzchiva® and Biocon Biologics’ Yesintek™ are two of the many ustekinumab biosimilars now available in the US.  This follows settlement agreements between J&J and the following companies: Amgen (which launched its biosimilar, Wezlana®, in the US in early January 2025 through Optum Health Solution’s private label subsidiary Nuvaila), Alvotech and Teva (Selarsdi® launched on 21 February 2025), Biocon (Yesintek™ launched on 24 February 2025), Samsung Bioepis’/Sandoz’s Pyzchiva® (February 2025), Celltrion (Steqeyma® launched March 2025), and Fresenius Kabi and Formycon (Otulfi® launched March 2025).  Other ustekinumab biosimilars launched in the US include Dong A-ST/Accord’s Imuldosa® (launched August 2025) and Bio-Thera/Hikma’s Starjemza™ (launched November 2025).

However, J&J continues to expand the approved indications for Stelara®.  Most recently, on 15 April 2026, the FDA approved Stelara® for the treatment of children two years and older with moderately to severely active Crohn’s disease.  Stelara® is now the only FDA-approved IL-12/23 antagonist and the first non-TNF biologic to treat adults and children with moderately to severely active Crohn’s disease.

On 4 May 2026, Lannett Company, with its wholly owned subsidiary, Lanexa Biologics, and Sunshine Lake Pharma (the pharmaceutical business arm of HEC Group) announced that the FDA has approved Langlara™ (insulin glargine-aldy), as an interchangeable biosimilar to Sanofi’s Lantus® (insulin glargine) for the treatment of certain adult and paediatric patients with diabetes.

Under a 2021 agreement, Sunshine Lake Pharma is responsible for manufacturing and supplying Langlara™, while Lanexa Biologics has the exclusive commercialisation rights in the US.  Langlara™ is Lanexa’s first insulin product, although it reportedly has a short acting insulin aspart under development.

In July 2025, Aurobindo Pharma agreed to acquire Lannett, with the US$250M transaction scheduled to take up to 12 months to complete.  Upon close of the acquisition, Lanexa will become a stand-alone company.

Biocon’s Semglee® was the first biosimilar approved in the United States as interchangeable to Sanofi’s Lantus® (insulin glargine) (July 2021) and was launched in November 2021.  Eli Lilly’s insulin glargine biosimilar, Rezvoglar®, was FDA-approved in December 2021.  Rezvoglar® later received approval as an interchangeable biosimilar to Lantus® in November 2022, ahead of its US launch in April 2023.  In October 2025, Biocon announced its plans to supply a new insulin glargine medicine in the US in collaboration with Civica.

On 1 May 2026, Janssen/Johnson & Johnson (J&J) announced that, on 15 April 2026, the FDA approved Stelara® (ustekinumab) for the treatment of children two years and older with moderately to severely active Crohn’s disease.  Stelara® is now the only FDA-approved IL-12/23 antagonist and the first non-TNF biologic to treat adults and children with moderately to severely active Crohn’s disease.

The approval is based on data from the Phase 3 UNITI-Jr clinical study, a multi-centre interventional study to evaluate the efficacy, safety, and pharmacokinetics of Stelara® for the treatment of paediatric Crohn’s disease over 52 weeks.

Stelara® is facing significant competition from biosimilars globally, including in the US, following settlement agreements with Amgen (which launched its biosimilar, Wezlana®, in the US in early January 2025 through Optum Health Solution’s private label subsidiary Nuvaila), Alvotech and Teva (Selarsdi® launched on 21 February 2025), Biocon (Yesintek™ launched on 24 February 2025), Samsung Bioepis’/Sandoz’s Pyzchiva® (February 2025), Celltrion (Steqeyma® launched March 2025) and Fresenius Kabi and Formycon (Otulfi® launched March 2025).  Other ustekinumab biosimilars launched in the US include Dong A-ST/Accord’s Imuldosa® (August 2025) and Bio-Thera/Hikma’s Starjemza™ (November 2025).

On 1 May 2026, Aurobindo announced that its subsidiary, CuraTeQ Biologics, received Canadian approval for Bevqolva™ (bevacizumab), biosimilar to Genentech’s Avastin®.  Bevqolva™ is indicated for various cancers and is available in 100 mg and 400 mg formulations.

CuraTeQ received approval for Bevqolva™ in the UK in December 2024 and the product is currently under regulatory review in Europe.

Bevacizumab biosimilars have been approved and available in Canada for many years, including Amgen’s Mvasi® (approved April 2018), Biocon’s Abevmy® (launched May 2022), Samsung Bioepis/Organon’s Aybintio® (launched November 2022) and Celltrion’s Vegzelma™ (approval announced January 2023).

The first bevacizumab biosimilar was approved in the US in September 2017 and in Europe in January 2018.

On 30 April 2026, Celltrion announced that it had submitted an application to the European Medicines Agency (EMA) for Herzuma® SC/CT-P6 SC, biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin Hylecta™).

The timing of the application aligns with Celltrion’s December 2025 announcement that it had been conducting clinical trials for Herzuma® SC (CT-P6 SC) since February 2025 and planned to submit applications for approvals of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026.  According to Celltrion, following the EMA, it plans to proceed with regulatory submissions for Herzuma® SC in other major countries.

There are currently no biosimilar SC formulations of trastuzumab on the market and Celltrion considers it is well-placed to enjoy a “first mover” advantage.  In January 2026, Biocon Biologics announced that it had added a trastuzumab/hyaluronidase product, referencing Roche’s Herceptin® SC/Herceptin Hylecta™, to its biosimilar development pipeline.

On 30 April 2026, Xbrane announced that it has resubmitted its BLA for biosimilar ranibizumab to the FDA following a Complete Response Letter (CRL) received in October 2025.  In November 2025, Xbrane had indicated that it expected to resubmit its BLA in March 2026.  However, following Xbrane’s contract manufacturer receiving “further detailed feedback from the FDA”, Xbrane’s resubmission plans were delayed.

The biosimilar to Genentech’s Lucentis® is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with Valorum Biologics, which will be responsible for commercialisation in the US.

There are currently three ranibizumab biosimilars approved in the US.  The first approved was Samsung Bioepis’ Byooviz® (September 2021), followed by Sandoz’s Cimerli® (August 2022, rights acquired by Sandoz from Coherus in March 2024) and Formycon’s Nufymco® (December 2025).

Xbrane’s ranibizumab biosimilar has been approved in the EU and UK since November 2022, under the name Ximluci®.  It was launched in the EU in April 2023.