Shots:
- Global biosimilar activity accelerated across ophthalmology, oncology, immunology, and diabetes, with new or advancing alternatives to Lucentis, Eylea, Stelara, Lantus, Avastin, Opdivo, and Neulasta, expanding patient access across Europe, the US, India, Canada, Ghana, and MENA
- Regulatory and commercialization momentum remained strong, marked by FDA, EC, Health Canada, and Ghana FDA milestones, alongside Samsung Bioepis’ direct commercialization shift and Fresenius Kabi’s new interchangeable Otulfi format, reinforcing confidence in biosimilar safety and equivalence
- Partnerships and settlement deals drove market entry, including agreements involving Alvotech, Samsung Bioepis, Regeneron, Bayer, MS Pharma, and Hetero, supporting broader global rollout, localized supply, and improved affordability
Company: Samsung Bioepis
Product: Byooviz
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: Jan 02, 2026
Shots:
- Samsung Bioepis has reported the direct commercialization of Byooviz, a biosimilar version of Lucentis (ranibizumab) across Europe, with market availability expected in Q2’26
- Byooviz (0.5 mg/0.05 ml) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV)
- Samsung Bioepis has regained commercial rights from Biogen, and BYOOVIZ will now be sold under the Samsung Bioepis brand in multiple EU countries
Company: CivicaScript
Product: Insulin Glargine-yfgn and Ustekinumab-aauz
Active Ingredient: Insulin Glargine and Ustekinumab
Reference Product: Lantus and Stelara
Reference Product Company: Sanofi and Johnson and Johnson
Disease: Diabetes Mellitus, Moderate to Severe Plaque Psoriasis, Active ulcerative Colitis, Active Crohn’s Disease, and Active Psoriatic Arthritis
Date: Jan 05, 2026
Shots:
- CivicaScript has reported that Insulin Glargine-yfgn and Ustekinumab-aauz, biosimilar versions of Lantus and Stelara, are now available in the US
- Civica insulin glargine-yfgn is an interchangeable Lantus® insulin for adults and children with diabetes, developed through a Civica-led collaboration. It is marketed nationally by CivicaScript and branded as CalRx in California through the state’s CalRx program
- Ustekinumab-aauz is an IL-12/23 antagonist indicated for select patients with plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, and is interchangeable with the reference product Stelara (ustekinumab)
Company: Fresenius Kabi
Product: Otulfi
Active Ingredient: Ustekinumab
Reference Product: Stelara
Reference Product Company: Johnson and Johnson
Disease: Moderate to Severe Plaque Psoriasis, Active ulcerative Colitis, Active Crohn’s Disease, and Active Psoriatic Arthritis
Date: Jan 06, 2026
Shots:
- Fresenius Kabi has launched Otulfi, an interchangeable biosimilar version of Stelara (ustekinumab), in a 45 mg/0.5 mL single-dose vial presentation for SC injection
- FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity of Otulfi vs Stelara among mod. to sev. plaque psoriasis pts
- Otulfi is also available in 45mg/0.5mL & 90mg/mL single-dose PFS for SC injection & a 130mg/26mL single-dose vial for IV infusion, since Mar 2025
Company: CuraTeQ Biologics
Product: Dyrupeg
Active Ingredient: pegfilgrastim
Reference Product: Neulasta
Reference Product Company: Amgen
Disease: Non-myeloid Cancers Undergoing Myelosuppressive Chemotherapy, Improve Survival After Acute Radiation Exposure (Hematopoietic Subsyndrome of ARS)
Date: Jan 09, 2026
Shots:
- CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has received NOC from the BRDD for Dyrupeg, a biosimilar to Neulasta (pegfilgrastim)
- Dyrupeg (pegfilgrastim) is a long-acting form of filgrastim that mimics human G-CSF, stimulating bone marrow to increase white blood cell production and treat neutropenia
- In 2025, Dyrupeg received marketing authorization from the EC and the UK MHRA, with three additional CuraTeQ biosimilar applications currently under review by Health Canada
Company: Bio Usawa
Product: BioUcenta
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: Jan 12, 2026
Shots:
- The Ghana FDA has approved BioUcenta, a biosimilar version of Lucentis (ranibizumab) for diabetic macular edema, age-related macular degeneration, and diabetic retinopathy
- The Ghana FDA approval followed a rigorous, science-based review referencing comprehensive data previously evaluated and accepted by the EMA
- BioUcenta is exclusively licensed to Bio Usawa for Sub-Saharan Africa by Bioeq AG
Company: Shanghai Henlius
Product: HLX04
Active Ingredient: Bevacizumab
Reference Product: Avastin
Reference Product Company: Genentech
Disease: Colorectal Cancer, Non-squamous Non-small Cell Lung Cancer, Recurrent Glioblastoma, Renal Cell Carcinoma, Cervical Cancer, Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer, and Hepatocellular Carcinoma
Date: Jan 13, 2026
Shots:
- The US FDA has accepted the BLA for HLX04, a biosimilar version of Avastin (bevacizumab)
- BLA was supported by analytical similarity studies, a P-I PK comparability trial in healthy subjects, and a multicenter P-III trial in pts with metastatic colorectal cancer, evaluating HLX04 vs the reference product for safety, PK, and immunogenicity
- Henlius is advancing a P-II/III trial of HLX04 + serplulimab for 1L colorectal cancer and has also developed an ophthalmic formulation, HLX04-O, for wAMD. The NDA for HLX04-O has been accepted by China’s NMPA, with a global P-III trial completed to support future worldwide filings
Company: Sandoz
Product: Ondibta
Active Ingredient: Insulin Glargine Injection
Reference Product: Lantus SoloStar
Reference Product Company: Sanofi
Disease: Diabetes Mellitus
Date: Jan 14, 2026
Shots:
- The EC has approved Ondibta, a biosimilar insulin glargine pre-filled pen, reference medicine Lantus and SoloStar, developed and registered by Gan & Lee Pharmaceuticals, anticipated launch by early 2027
- Ondibta is approved for treating diabetes mellitus in pts (age≥ 2 yrs.) and matches Lantus, SoloStar in safety, quality, and efficacy
- In Dec 2018, Sandoz partnered with Gan & Lee to commercialize biosimilar insulins (glargine, lispro, and aspart), with Sandoz handling commercialization across Europe & key territories and Gan & Lee overseeing development, registration, manufacturing, and supply
Company: Zydus Lifesciences
Product: Tishtha
Active Ingredient: Nivolumab
Reference Product: Opdivo
Reference Product Company: BMS
Disease: Renal Cell Carcinoma, Melanoma, Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Cancer, and Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma
Date: Jan 22, 2026
Shots:
- Zydus Lifesciences has reported Tishtha, biosimilar version of Opdivo (Nivolumab), is now available in the India
- Tishtha will be available in 100 mg and 40 mg strengths
- Nivolumab is a mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma
Company: MS Pharma and Hetero
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: Jan 26, 2026
Shots:
- MS Pharma has signed a strategic partnership with Hetero to localize five established biosimilars across key areas, including oncology, immunology, and hematology, in the MENA region
- The exclusive agreement will be implemented through El Kendi (MS Pharma Group’s Algeria affiliate) and Hetero Biopharma, a subsidiary of Hetero Group
- This marks Hetero’s first local partnership in Algeria, supporting the growth of the country’s biopharmaceutical ecosystem
Company: Alvotech, Regeneron, and Bayer
Product: Eylea
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: Jan 29, 2026
Shots:
- Alvotech has signed a settlement and license agreement with Regeneron and Bayer for Eylea 2 mg (aflibercept) biosimilar. With prior US rights effective Q4’26, Alvotech now holds worldwide manufacturing and supply rights for its commercial partners
- The settlement enables Alvotech and partners to launch the biosimilar from Jan 1, 2026, in the UK and Canada, May 1, 2026, in the EEA and other non-US markets, and Japan (excluding DME) and Nov 1, 2026, with all approved indications in Japan. Other terms remain confidential
- Alvotech’s Eylea biosimilar partners include Advanz Pharma (UK/EEA), STADA (Germany), and Biogaran (France) in the EU, and Fuji Pharma in Japan. The product is approved as Mynzepli and Afiveg in the EU, Mynzepli® in the UK, and Aflibercept BS in Japan
Company: Samsung Bioepis, Regeneron, and Bayer
Product: SB15
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: Jan 30, 2026
Shots:
- Samsung Bioepis has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of SB15, a biosimilar version of Eylea 2 mg (aflibercept 40 mg/mL solution), in markets excluding the US and Canada
- The agreement allows Samsung Bioepis to launch SB15 in the UK from Jan 2026, across the EU from Apr 2026, and in other settled markets (excluding Korea) from May 2026, with the remaining terms kept confidential
- Samsung Bioepis’ OPUVIZ™ (aflibercept 40 mg/mL) received approval from the European Commission in Nov 2024 and the UK MHRA in Apr 2025
Note: The following drug has been granted CHMP; however, no PR was available:
- Osqay (Biosimilar, Prolia)
Related Post: Key Biosimilars Events of December 2025
