Shots:
- Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars.
- Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon, and SteinCares signed commercialization and licensing deals across Canada, APAC, MENA, and LATAM, strengthening biosimilar pipelines in oncology, immunology, and ophthalmology.
- Clinical and manufacturing milestones advanced pipelines with positive PK and pivotal data reported for Keytruda, Entyvio, and Herceptin biosimilars, alongside FDA clearances, BLA acceptances, and facility approvals such as Rezon Bio’s Warsaw-Duchnice site, reinforcing manufacturing readiness and upcoming 2026–2027 launches.
Company: Sandoz
Product: Enzeevu
Active Ingredient: Aflibercept
Reference Product: Eylea
Reference Product Company: Bayer
Disease: Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy, and Retinopathy of Prematurity
Date: Feb 02, 2026
Shots:
- Sandoz has reported Enzeevu (Aflibercept), a biosimilar version of Eylea, is now available in Canada
- Enzeevu is a single-use, PFS intravitreal injection delivering 2 mg aflibercept (2 mg/0.05 mL). It closely resembles the reference product
- Enzeevu is approved for all its indications, including neovascular (wet) age-related macular degeneration (AMD), macular edema due to CRVO or BRVO, diabetic macular edema (DME), and myopic choroidal neovascularization (CNV)
Company: Celltrion
Product: Herzuma SC (CT-P6 SC)
Active Ingredient: Trastuzumab
Reference Product: Herceptin
Reference Product Company: Teva
Disease: Breast & Gastric Cancers
Date: Feb 02, 2026
Shots:
- Celltrion has completed the trial for Herzuma SC (CT-P6 SC), a biosimilar version of Herceptin (trastuzumab), and plans to file for marketing approval in the EU and Korea within three months
- The trial, which demonstrated PK equivalence to the reference SC formulation, along with comparable safety and immunogenicity, also met its 1EP. Herzuma SC is also expected to enhance patient convenience by reducing administration time from about 90 minutes with the IV version to approximately five minutes
- Celltrion has demonstrated its capabilities in SC commercialization with Remsima SC (U.S. brand: Zymfentra) and now plans to expand into CMO services, leveraging its SC formulation expertise to support external partners
Company: Alvotech and Sandoz
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: Feb 02, 2026
Shots:
- Alvotech has entered into supply & commercialization agreements with Sandoz for multiple biosimilar candidates across Canada, Australia, & New Zealand
- In Canada, the deal includes one ophthalmology biosimilar in a prefilled intravitreal syringe, while in Australia & New Zealand it covers 3 biosimilar candidates across immunology & gastroenterology in multiple formulations
- As per the deals, Alvotech will handle development, global clinical activities, manufacturing & finished product supply, while Sandoz will be responsible for regulatory filings, commercialization & distribution
Company: Bio-Thera and Avalon Pharma
Product: BAT3306
Active Ingredient: Pembrolizumab
Reference Product: Keytruda
Reference Product Company: Merck
Disease: All Approved Indications
Date: Feb 03, 2026
Shots:
- Bio-Thera and Avalon Pharma have signed commercialization and licensing agreements for BAT3306, a biosimilar version of Keytruda (Pembrolizumab)
- As per the deal, Bio-Thera will oversee development, manufacturing, and supply of BAT3306, while Avalon Pharma will handle regulatory approvals and commercialization across Saudi Arabia and the MENA region
- BAT3306 is a humanized monoclonal antibody and immune checkpoint inhibitor for cancer immunotherapy. Like pembrolizumab, it blocks the PD-1 receptor on T cells, preventing its interaction with PD-L1 and PD-L2 to enhance anti-tumor immune response
Company: Saya Biologics and Kashiv BioSciences
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: Feb 04, 2026
Shots:
- Saya Biologics has signed a strategic partnership with Kashiv BioSciences to register and commercialize a supportive oncology therapy in Mexico and the CAC region
- As per the deal, the agreement spans 11 countries across Mexico and the CAC region. Saya Biologics will handle regulatory registration, commercialization, and distribution, while Kashiv BioSciences will oversee manufacturing and supply.
- Saya has already submitted the regulatory dossier in Mexico, marking a key milestone toward patient access
Company: Alvotech
Product: AVT80
Active Ingredient: Vedolizumab
Reference Product: Entyvio
Reference Product Company: Takeda
Disease: Mod. to Sev. Active Ulcerative Colitis & Crohn’s Disease
Date: Feb 05, 2026
Shots:
- Alvotech reported positive top-line data from the AVT80-GL-P01 PK study comparing AVT80 with Entyvio in healthy adults
- The study met all 1EP, demonstrating PK similarity between AVT80 & Entyvio following a single 108mg/0.68mL SC dose, supporting AVT80’s biosimilar profile
- Alvotech is developing AVT16 (IV) & AVT80 (SC) as Entyvio’s biosimilars, with the AVT80-GL-P01 study demonstrating PK similarity across both routes & serving as a pivotal trial to support clinical similarity for both candidates based on regulatory advice
Company: Formycon & Lotus Pharmaceutical
Product: FYB206
Active Ingredient: Pembrolizumab
Reference Product: Keytruda
Reference Product Company: Merck
Disease: All Approved Indications
Date: Feb 11, 2026
Shots:
- Formycon & Lotus have reported the conclusion of their exclusive license agreement for Formycon’s FYB206, a biosimilar version of Keytruda (Pembrolizumab), in the APAC market
- Upon closing, Formycon will receive an upfront payment, plus potential development & regulatory milestone payments, & a share of gross profits after launch, while retaining responsibility for manufacturing & supplying the finished product
- FYB206 is nearing completion of clinical development, with 1EP data expected in Q1’26, after which Formycon & Lotus will coordinate preparation of regulatory submissions across APAC markets in line with local requirements
Company: Samsung Bioepis and Regeneron
Product: Opuviz
Active Ingredient: Aflibercept
Reference Product: Eylea
Reference Product Company: Bayer
Disease: Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy, and Retinopathy of Prematurity
Date: Feb 12, 2026
Shots:
- Samsung Bioepis has signed a settlement and license agreement with Regeneron for the commercialization of Opuviz, a biosimilar version of Eylea 2 mg, in the US, following an earlier settlement covering Europe and the Rest of the World (RoW)
- Samsung Bioepis will launch Opuviz 2 mg in the US starting January 2027 under this agreement, with other terms remaining confidential
- In May 2024, The US FDA has approved Samsung Bioepis’ OPUVIZ 2 mg (aflibercept-yszy)
Company: STADA & Bio-Thera
Product: Gotenfia
Active Ingredient: Golimumab
Reference Product: Simponi
Reference Product Company: Johnson & Johnson
Disease: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Ulcerative Colitis
Date: Feb 13, 2026
Shots:
- The EC has approved STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), in all 30 EEA states, with launch preparations ongoing
- Approval was based on extensive analytical, non-clinical & clinical data demonstrating biosimilarity of BAT2506 to Simponi
- In May 2024 deal, STADA obtained exclusive commercial rights to Gotenfia in the EU, UK, Switzerland & selected other countries, while Bio-Thera handled its development, manufacturing, & supply, expanding it to cover tocilizumab biosimilar (in 2025) for which launch preparations are also underway
Company: Henlius
Product: HLX15-SC
Active Ingredient: Daratumumab
Reference Product: Darzalex Faspro
Reference Product Company: Johnson & Johnson
Disease: Mulitple Myeloma, and Light Chain (AL) Amyloidosis
Date: Feb 13, 2026
Shots:
- The US FDA has granted IND clearance to initiate P-I trial of HLX15-SC, a biosimilar version of Darzalex Faspro (daratumumab), for the 1L treatment of multiple myeloma
- In Jun 2024, the P-I study of HLX15 (IV; Biosimilar, Darzalex) met its 1EP, demonstrating similar PK & comparable safety & immunogenicity to US, EU, & China-sourced daratumumab
- Additionally, in Feb 2025, Henlius signed a licensing & collaboration deal with Dr. Reddy’s Laboratories, granting exclusive rights for the IV & SC formulations of HLX15 in the US & 42 EU countries
Company: Accord BioPharma
Product: Filkri
Active Ingredient: Filgrastim
Reference Product: Neupogen
Reference Product Company: Amgen
Disease: Non-myeloid Cancers Undergoing Myelosuppressive Chemotherapy, Improve Survival After Acute Radiation Exposure (Hematopoietic Subsyndrome of ARS), Acute Myeloid Leukaemia, Reduce the Duration of Neutropenia and Neutropenia-related Clinical Sequelae, Mobilize Autologous Hematopoietic Progenitor Cells, and Reducing the Incidence and Duration of Severe Neutropenia in Congenital Neutropenia‚ Cyclic Neutropenia‚ or Idiopathic Neutropenia
Date: Feb 17, 2026
Shots:
- FDA has approved Filkri, a biosimilar to Neupogen (filgrastim), for pts receiving myelosuppressive CT, those with AML receiving induction or consolidation CT, cancer pts undergoing bone marrow transplant, pts with sev. chronic neutropenia, & pts exposed to myelosuppressive radiation
- Approval was supported by 2 studies in healthy adults, with PK/PD assessed in one, & safety & immunogenicity evaluated in both against Neupogen, showing comparable PK/PD profiles, along with similar safety & immunogenicity outcomes
- Accord has also applied for a permanent Q-code from the US CMS to streamline & standardize billing & reimbursement procedures across various settings
Company: Sandoz
Product: Enzeevu
Active Ingredient: Aflibercept
Reference Product: Eylea
Reference Product Company: Bayer
Disease: Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy, and Retinopathy of Prematurity
Date: Feb 18, 2026
Shots:
- The US FDA has approved Enzeevu, a biosimilar version of Eylea (aflibercept), for multiple retinal indications, with an anticipated launch in Q4’26
- Aflibercept is a recombinant fusion protein that blocks VEGF-A and PlGF, inhibiting abnormal blood vessel growth
- Enzeevu (aflibercept-abzv) is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic retinopathy (DR), and diabetic macular edema (DME)
Company: Rezon Bio
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: Feb 18, 2026
Shots:
- The US FDA grants approval for commercial manufacturing of a biosimilar at Rezon Bio’s Warsaw-Duchnice facility
- The FDA approval of the Warsaw-Duchnice facility follows a comprehensive review process and indicates that the site meets regulatory standards for quality systems, technical capabilities, and operational readiness to supply the US market
- This approval follows earlier EMA GMP certification and authorization for commercial supply in European markets
Company: Zydus Lifesciences
Product: Anyra
Active Ingredient: Aflibercept
Reference Product: Eylea
Reference Product Company: Bayer
Disease: Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy, and Retinopathy of Prematurity
Date: Feb 19, 2026
Shots:
- Zydus Lifesciences has launched Anyra (aflibercept 2 mg), a biosimilar version of Eylea. Zydus has inked an agreement with Regeneron and Bayer
- Aflibercept is a Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF), which are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial cells
- Anyra is approved for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD), visual impairment due to macular edema secondary to Retinal Vein Occlusion (Branch RVO or Central RVO), visual impairment due to Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and visual impairment due to Myopic Choroidal Neovascularization (mCNV)
Company: Dr. Reddy
Product: DRL_AB
Active Ingredient: Abatacept
Reference Product: Orencia
Reference Product Company: BMS
Disease: Mod. To Sev. Active Rheumatoid Arthritis & Polyarticular Juvenile Idiopathic Arthritis, Active Psoriatic Arthritis, and Prophylaxis of Acute Graft Versus Host Disease
Date: Feb 20, 2026
Shots:
- The US FDA has accepted 351 (k) BLA for DRL_AB (IV), a proposed interchangeable biosimilar to Orencia (abatacept)
- Upon approval, DRL_AB will be indicated for adults with mod. to sev. active rheumatoid arthritis, adults with active psoriatic arthritis, & pts (≥6yrs.) with mod. to sev. active polyarticular juvenile idiopathic arthritis
- BLA was supported by extensive clinical data. DRL_AB showed PK similarity with comparable safety & immunogenicity to Orencia in the P-I (AB-01-003) trial & is being evaluated in the P-III (AB-01-004) study assessing its efficacy & safety against Orencia
Company: Lupin and Sandoz
Product: Ranluspec
Active Ingredient: Ranibizumab
Reference Product: Lucentis
Reference Product Company: Genentech
Disease: Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy, and Myopic Choroidal Neovascularization
Date: Feb 23, 2026
Shots:
- The EC has approved Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab)
- Ranibizumab is a recombinant humanized IgG1 antibody fragment that inhibits VEGF-A and is used to treat wet AMD, macular edema due to retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization
- Sandoz and Lupin Limited partnered in August 2025 to develop and commercialize a ranibizumab biosimilar. Sandoz holds exclusive EU rights to Ranluspec (excluding Germany) and semi-exclusive rights in France, while commercializing Epruvy (ranibizumab) in Germany under a separate agreement
Company: Formycon & Zydus Lifescience
Product: FYB206
Active Ingredient: Pembrolizumab
Reference Product: Keytruda
Reference Product Company: Merck
Disease: All Approved Indications
Date: Feb 25, 2026
Shots:
- Formycon & Zydus Lifescience has reported that the pivotal Dahlia PK study of FYB206, a biosimilar version of Keytruda (pembrolizumab), has met its 1EP
- The multicenter PK study showed bioequivalence of FYB206 (pembrolizumab) to Keytruda
- Zydus Lifesciences has exclusively in-licensed FYB206, a proposed biosimilar to Keytruda (pembrolizumab), from Formycon for the US and Canada
Company: SteinCares and Shilpa Biologicals
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: Feb 25, 2026
Shots:
- SteinCares has entered into a strategic licensing agreement with Shilpa Medicare to commercialize a biosimilar across Latin America (LATAM)
- As per the deal, SteinCares secures exclusive rights to register, commercialize, & distribute the biosimilar across the region, while SBPL will finalize development & undertake commercial manufacturing at its Dharwad, India facility
- Partnership combines SBPL’s biologics development & high-quality commercial manufacturing capabilities with SteinCares’ integrated regional platform, accelerating market access, & expanding the reach of advanced biologics across key LATAM markets
Company: Gedeon Richter
Product: Tuyory
Active Ingredient: Tocilizumab
Reference Product: RoActemra
Reference Product Company: Roche
Disease: Rheumatoid Arthritis, Giant Cell Arteritis, Systemic Sclerosis-Associated Interstitial Lung Disease, Polyarticular Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis, Cytokine Release Syndrome, and COVID-19
Date: Feb 27, 2026
Shots:
- The CHMP has recommended marketing authorization for Gedeon Richter’s Tuyory, a biosimilar version of RoActemra (Tocilizumab)
- Tuyory (tocilizumab) inhibits IL-6 signaling and is indicated for rheumatoid arthritis, juvenile idiopathic arthritis (including polyarthritis), giant cell arteritis, cytokine release syndrome, and COVID-19. It is available in both IV and SC forms, with dosing and presentations matching the reference product
- Tuyory was co-developed by Gedeon Richter and Mochida Pharmaceutical
Company: Gan & Lee Pharmaceuticals
Product: Bysumlog and Dazparda
Active Ingredient: Insulin Lispro & Aspart
Reference Product: Humalog and NovoRapid
Reference Product Company: Novo Nordisk and Eli Lilly
Disease: Improve Glycemic Control in Adults, and Pediatric Patients with Diabetes Mellitus
Date: Feb 27, 2026
Shots:
- The CHMP has recommended marketing authorization for Bysumlog (insulin lispro) and Dazparda (insulin aspart), a biosimilar version of Humalog and NovoRapid respectively across all 30 EEA states
- Opinion was supported by P-I demonstrating biosimilarity and comparable safety of Bysumlog vs Humalog and Dazparda vs NovoLog/NovoRapid.
- Gan & Lee Pharmaceuticals signed a development, license, and commercialization agreement with Sandoz for three insulin biosimilars: glargine, lispro, and aspart. Upon approval, Sandoz will commercialize them in Europe and other key markets, while Gan & Lee will handle manufacturing and supply
Note: The following drug has been granted CHMP; however, no PR was available:
- Fubelv (Biosimilar, Enbrel)
- Poherdy (Biosimilar, Perjeta)
- Zandoriah (Biosimilar, Forsteo)
Related Post: Key Biosimilars Events of January 2026
