On 27 February 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended indication extensions for 6 medicines, 3 of which are biopharmaceuticals: Sanofi/Regeneron’s Dupixent®, MSD’s Keytruda® and Janssen’s Stelara®.

Sanofi/Regeneron’s Dupixent® (dupilumab) received a positive recommendation for the treatment of children aged 2 to 11 years with moderate to severe chronic spontaneous urticaria (CSU).  The existing CSU indication in Europe (approved in November 2025) covers adults and adolescents (12 years and above).  According to Regeneron’s press release, an sBLA has been accepted for review in the US seeking approval for Dupixent® in children aged 2 to 11 years with CSU, with a decision expected by April 2026.

The CHMP also recommended indication of MSD’s Keytruda® (pembrolizumab), in combination with paclitaxel (with/without bevacizumab), for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in certain adults.

Janssen’s Stelara® (ustekinumab) received a recommendation for a change to its indication for paediatric Crohn’s disease for children from 2 years of age, from the current indication of paediatric patients weighing at least 40 kg.

Biosimilar launches, approvals and/or development are well underway for each of dupilumab, pembrolizumab and ustekinumab:

• Companies with dupilumab biosimilars in development include Alvotech, Samsung Bioepis, Formycon, Mabwell, Chong Kun Dang. CSPC Pharmaceutical, and Bio-Thera Solutions.
• Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025).  Pembrolizumab biosimilars are also under development including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, BioNTech, Alvotech and Formycon.
• Ustekinumab biosimilars were launched in Europe in July 2024 by STADA/Alvotech (Uzpruvo®) and Sandoz (Pyzchiva®). Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).

On 25 February 2026, Formycon and Zydus announced positive results from the phase 1 pharmacokinetic study (“Dahlia”) for FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab).  The study, commenced in June 2024, is reported to have met its primary objective and demonstrated bioequivalence of FYB206 and Keytruda®.

The study is part of a streamlined clinical strategy agreed by Formycon with the FDA in relation to FYB206.  In February 2025, Formycon announced it would terminate a Phase 3 trial of FYB206, which commenced in June 2024 as it was no longer necessary for FDA approval.  Instead, Formycon intends to rely on data from the “Dahlia” trial, combined with a comprehensive analytical program to support its regulatory applications, with the aim of making FYB206 available “as soon as possible after the exclusivity” of Keytruda® expires.

Zydus has the exclusive rights to commercialise FYB206 in the US and Canada under an agreement with Formycon announced in December 2025.  Zydus is hoping to be the first to file a Biologics Licence Application for biosimilar pembrolizumab in the US.  Formycon has also recently announced FYB206 commercialisation agreements with MS Pharma (for the MENA Region) and Lotus Pharmaceutical (for parts of Asia Pacific).

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).  Pembrolizumab biosimilars in clinical trials include Amgen’s ABP 234 (Ph 3 in early stage nsNSCLC initiated May 2024, Ph 3 in advanced or metastatic nsNSCLC commenced September 2024), Bio-Thera’s BAT3306 (integrated PhI/III trial commenced, Ph 3 terminated July 2025 due to regulatory developments), Celltrion’s CT-P51 (Ph 3 trial approved by FDA in August 2024, initiated January 2025), Sandoz’s GME751 (Ph 1 commenced in May 2024, estimated completion July 2026), mAbxience’s MB12 (Ph 3 study commenced December 2024, estimated completion June 2026), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024, expected completion September 2026) and Shanghai Henlius’ HLX17 (approval for clinical trial received September 2024).  Biocon and Alvotech have pembrolizumab biosimilars in their pipelines.

On 24 February 2026, Sana Pharma announced that Pembrava™, biosimilar to MSD’s Keytruda® (pembrolizumab), has been registered by the Jordan Food and Drug Administration for cancer treatment.  Sana Pharma claims that Pembrava™ is the first biosimilar for cancer treatment in Jordan.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025).  There are a number of pembrolizumab biosimilars in clinical trials including Amgen’s ABP 234 (Ph 3 in early stage nsNSCLC initiated May 2024, Ph 3 in advanced or metastatic nsNSCLC commenced September 2024), Bio-Thera’s BAT3306 (integrated PhI/III trial commenced, Ph 3 terminated July 2025 due to regulatory developments), Celltrion’s CT-P51 (Ph 3 trial approved by FDA in August 2024, initiated January 2025), Formycon’s FYB206 (Ph 1/3 trial commenced June 2024 in melanoma), Sandoz’s GME751 (Ph 1 commenced in May 2024, estimated completion July 2026), mAbxience’s MB12 (Ph 3 study commenced December 2024, estimated completion June 2026), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024, expected completion September 2026) and Shanghai Henlius’ HLX17 (approval for clinical trial received September 2024).  Biocon and Alvotech have pembrolizumab biosimilars in their pipelines.

On 17 February 2026, MSD announced that Health Canada has approved Keytruda SC™ (pembrolizumab), a subcutaneous (SC) formulation of pembrolizumab injection for multiple cancer indications.

The Canadian approval follows European approval of Keytruda SC™ in November 2025, after a positive recommendation from the EMA’s CHMP in September 2025.  However, in December 2025, the Munich Regional Court granted a preliminary injunction to Halozyme, preventing MSD from distributing and offering for sale in Germany Keytruda SC™.  The decision was based on a finding of the Court that there was imminent infringement of one of Halozyme’s European MDASE™ patents, EP 2797622, in relation to modified PH20 hyaluronidase polypeptides and compositions.

MSD’s subcutaneous formulation of pembrolizumab was approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications.  Halozyme has also sued MSD in the US in relation to SC pembrolizumab.

While there are no reports as yet of biosimilar subcutaneous pembrolizumab, there are multiple pembrolizumab biosimilars approved or in development.  Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025).  Pembrolizumab biosimilars are also in clinical trials including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera and BioNTech.

Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.  Formycon has announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region, Zydus Lifesciences for the US and Canada, and Lotus for the Asia-Pacific.

On 11 February 2026, Formycon and Taiwan-based Lotus Pharmaceutical announced they have concluded an exclusive licence agreement in relation to the commercialisation of Formycon’s FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab), in major parts of the Asia-Pacific region.

Under the agreement, Formycon will be responsible for manufacturing and supplying the pembrolizumab biosimilar, with both companies “closely aligning” to prepare regulatory submissions in the relevant APAC countries.  Formycon will receive an upfront payment upon execution of the agreement, and further payments depending on the achievement of development and regulatory milestones.  Formycon will also receive a share of the gross profits upon launch of the product in the licensed countries.

This is the third agreement Formycon has concluded recently in relation to FYB206.  In December 2025, Formycon announced agreements with MS Pharma for the MENA region and Zydus Lifesciences for the US and Canada.

Formycon commenced an integrated Ph1/3 study 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 “Lotus” Phase 3 trial on the basis that the trial was not necessary to obtain US approval of FYB206.

A pembrolizumab biosimilar has reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025).  Pembrolizumab biosimilars are also under development including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera and BioNTech.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar in Saudi Arabia/MENA.

Formycon/Klinge and Lotus have previously partnered (February 2025) in relation to FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in the following Asia-Pacific countries: Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam and Hong Kong.

During its Q3 FY26 Earnings Call on 10 February 2026, Zydus Lifesciences indicated that it is hoping to be the first to file a Biologics Licence Application in the US for a pembrolizumab biosimilar and may potentially be first to launch in the US, subject to regulatory approvals.

The optimism comes after Zydus entered into an exclusive licensing and supply agreement with Formycon in December 2025 for the commercialisation of Formycon’s FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab), in the US and Canada.  According to Zydus, Formycon is “the furthest ahead in terms of the clinical development and FDA guidance” in relation to biosimilar pembrolizumab.

Formycon commenced an integrated Ph1/3 study 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.

Other pembrolizumab biosimilars in clinical trials include Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024, initiated January 2025), Amgen’s ABP 234 (Ph 3 in early stage nsNSCLC initiated May 2024, Ph 3 in advanced or metastatic nsNSCLC commenced September 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024), Sandoz’s GME751 (Ph 1 commenced in May 2024), Henlius’ HLX17 (approval for clinical trial received September 2024), and mAbxience’s MB12 (Ph 3 study commenced December 2024).

On 3 February 2026, Bio-Thera Solutions and Saudi-based Avalon Pharma announced that they have entered commercialisation and licence agreements for Bio-Thera’s BAT3306, biosimilar to MSD’s Keytruda® (pembrolizumab), in Saudi Arabia and MENA.

Under the agreement, Avalon will be responsible for seeking regulatory approvals and commercialisation in Saudi Arabia and MENA, while Bio-Thera will retain responsibility for development, manufacturing and supply of BAT3306.

Bio-Thera commenced an integrated Phase 1/III trial to evaluate the PK, efficacy and safety of BAT3306 in patients with non-squamous, non-small cell lung cancer (NSCLC) in July 2024.  According to the US clinicaltrials.gov database, that trial was terminated in July 2025 on the basis that “new regulatory developments” have resulted in Bio-Thera concluding that “a Phase 3 study is no longer necessary for the development and approval of BAT3306”.  Bio-Thera completed a Phase 1 study of BAT3306 in healthy male subjects in June 2024.  It has started recruiting for a Phase 1 trial comparing the PK similarity of BAT2206 and Keytruda® in patients with early stage NSCLC, with an estimated completion dated in 2027.

In August 2025, Bioéticos launched the first pembrolizumab biosimilar in Paraguay under the name Pembrolizumab Bioéticos. In November 2025, Biocad’s Pembroria™ (pembrolizumab) was approved in Vietnam.

BAT3306 joins a raft of other pembrolizumab biosimilars currently in clinical trials, including Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024, initiated January 2025), Amgen’s ABP 234 (Ph 3 in early stage nsNSCLC initiated May 2024, Ph 3 in advanced or metastatic nsNSCLC commenced September 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024), Sandoz’s GME751 (Ph 1 commenced in May 2024), Formycon’s FYB206 (Ph 1/3 trial commenced June 2024 in melanoma), Henlius’ HLX17 (approval for clinical trial received September 2024), mAbxience’s MB12 (Ph 3 study commenced December 2024).

In June 2025, Alvotech and Dr Reddy’s announced that they entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a pembrolizumab biosimilar.  In December 2025, Formycon announced agreements with MS Pharma for the commercialisation of pembrolizumab biosimilar FYB206 in the MENA region and with Zydus Lifesciences for the US and Canada.

On 3 February 2026, Amgen announced its financial results for Q4/2025 and full year 2025, including providing the following update on its biosimilar pipeline:

• Nivolumab: Amgen has completed enrolment in a comparative clinical study comparing ABP 206 (nivolumab) with the reference product, BMS’ Opdivo®, in patients with early-stage non-squamous NSCLC as adjuvant treatment. According to the US clinicaltrials.gov database, Amgen completed a Phase 3 study to compare the pharmacokinetic similarity of ABP 206 with Opdivo® in patients with resected advanced melanoma in October 2025.

• Ocrelizumab: A pharmacokinetic similarity/comparative clinical study of ABP 692 compared to Genentech/Roche’s Ocrevus® is enrolling patients with relapsing-remitting multiple sclerosis.  Amgen announced this Phase 3 study at the JP Morgan Annual Healthcare conference on 13 January 2025.

• Pembrolizumab: Two clinical trials are underway. Amgen completed enrolment in a combined pharmacokinetic/comparative clinical study of ABP 234 (pembrolizumab) with MSD’s Keytruda® in patients with advanced or metastatic non-squamous NSCLC (initiated May 2024) and is currently enrolling patients in a pharmacokinetic similarity study comparing ABP 234 with Keytruda® in patients with early-stage non-squamous NSCLC as adjuvant treatment.

Amgen reported that its biosimilars segment delivered US $3 billion in 2025 sales, an increase of 37% year-over-year, with particularly strong performance from Pavblu®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), which reached US $700 million in full year sales.  Pavblu® was the first aflibercept biosimilar launched in the US in October 2024 and remains the only aflibercept biosimilar on the US market to date (following settlements, launches of Biocon’s, Formycon/Klinge’s, Sandoz’s, Celltrion’s and Alvotech/Teva’s aflibercept biosimilars are planned in the second half of 2026).  At the same time, Amgen acknowledged that biosimilars are applying competitive pressure in relation to sales of Prolia® and Xgeva® (denosumab).

Nivolumab, pembrolizumab and ocrelizumab biosimilars have been developed, or are in development, by a number of other companies:

• Nivolumab: In January 2026, Zydus was the first to market its nivolumab biosimilar, Tishtha®, in India.  Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius, Enzene, Reliance Life Sciences and Biocon all have nivolumab biosimilars in their pipelines.

• Ocrelizumab biosimilars are in clinical trials sponsored by Biocad (Phase III, enrolment commenced November 2025), Sandoz (comparative pharmacokinetic trial underway), and Celltrion (Phase III IND for CT-P53 partially approved by the EMA in August 2023). Samsung Bioepis announced in January 2026 that it had added an ocrelizumab biosimilar to its pipeline.

• Pembrolizumab: In August 2025, Bioéticos launched the first pembrolizumab biosimilar in Paraguay under the name Pembrolizumab Bioéticos. In November 2025, Biocad’s Pembroria™ (pembrolizumab) was approved in Vietnam.  A number of other pembrolizumab biosimilars are currently in clinical trials, including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera and BioNTech.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®.  In December 2025, Formycon announced agreements with MS Pharma for the commercialisation of pembrolizumab biosimilar FYB206 in the MENA region and with Zydus Lifesciences for the US and Canada.

At its December 2025 Intracycle Meeting (the outcomes of which were published on 30 January 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended a broad, multi-indication PBS listing of MSD’s Keytruda® (pembrolizumab) for the treatment of advanced or metastatic cancers.

The recommendation comes after MSD received a knock-back from PBAC for the multi-indication (broad) listing for Keytruda® in July 2025.  At that time, in a decision MSD described as “bewildering”, PBAC had considered that because the proposed funding model “was restricted to the indications for which pembrolizumab was registered with the Therapeutic Goods Administration” it “would not provide access to some patient groups in which there is a significant unmet clinical need, such as rare cancers.”  In reporting the outcomes of the December 2025 meeting, the PBAC noted that MSD has now “largely addressed its concerns from the July 2025 submission”.

The PBAC recommendation for Keytruda® follows a similar recommendation, made at PBAC’s September 2025 meeting, for a broad, multi-indication listing for BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) in advanced or metastatic cancers.

The PBAC has recommended that pembrolizumab join the Risk Sharing Arrangement (RSA) that it had previously recommended for the nivolumab/ipilimumab broad listing (if that proceeds to listing), given that there are several indications where both pembrolizumab and nivolumab (± ipilimumab) would be treatment options in the same or similar population.  The PBAC has asked the Department of Health to review each of the recommended broad listings after three years to ensure the use remained consistent with its intention.

In August 2025, Bioéticos launched the first pembrolizumab biosimilar in Paraguay under the name Pembrolizumab Bioéticos.  In November 2025, Biocad’s Pembroria™ (pembrolizumab) was approved in Vietnam.  A number of other pembrolizumab biosimilars are currently in clinical trials, including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera and BioNTech.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®.  In December 2025, Formycon announced agreements with MS Pharma for the commercialisation of pembrolizumab biosimilar FYB206 in the MENA region and with Zydus Lifesciences for the US and Canada.

On 6 January 2026, Biocon Biologics announced that it will unveil three new biosimilars at the 2026 J.P. Morgan Healthcare Conference to be held 12-16 January 2026 in San Francisco.  The as yet unnamed biosimilars are for pembrolizumab (referencing MSD’s Keytruda®), nivolumab (referencing BMS’ Opdivo®) and trastuzumab/hyaluronidase (referencing Roche’s Herceptin® SC, marketed in the US as Herceptin Hylecta™).  The stage of development of each of the biosimilars is not yet known.

Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay in August 2025 under the name Pembrolizumab Bioéticos.  In November 2025, Biocad’s Pembroria™ (pembrolizumab) was reportedly approved in Vietnam.  A number of other pembrolizumab biosimilars are currently in clinical trials, including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera and BioNTech.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®.  In December 2025, Formycon announced agreements with MS Pharma for the commercialisation of pembrolizumab biosimilar FYB206 in the MENA region and with Zydus Lifesciences for the US and Canada.

There are a number of nivolumab biosimilars already undergoing clinical trials, including Sandoz’s JPB898 (phase I), Amgen’s ABP 206 (phase III), Xbrane/Intas’ Xdivane™ (phase I/III), Boan Biotech’s BA1104 (phase III), and Reliance Life Sciences’ R-TPR-067 (phase I/III).  In December 2025, Shanghai Henlius announced that the FDA approved an IND for a phase I trial of HLX18 (nivolumab).

Celltrion announced in December 2025 that it has been conducting clinical trials for Herzuma® SC (CT-P6 SC), biosimilar to Roche’s Herceptin® SC/Herceptin Hylecta™, since February 2025 and plans to submit applications for approvals of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026.