Shots:
- Regulatory momentum accelerates globally, with major approvals across the US, EU, UK, and Canada for biosimilars targeting high-value biologics such as Simponi, Stelara, Perjeta, Prolia/Xgeva, Remicade, Xolair, Eylea, Lucentis, and Lantus SoloStar, strengthening patient access in immunology, oncology, ophthalmology, diabetes, and allergy/asthma
- Sandoz, Alvotech, Celltrion, Henlius/Organon, Teva, and others expand portfolios and market reach, including multiple EC and FDA approvals, launches (e.g., Tyruko, Epruvy), and major licensing deals—highlighting intensified competition and diversification across biosimilar categories
- Strategic partnerships and acquisitions shape the next decade of biosimilar growth, including Sandoz’s $350M acquisition of Just-Evotec Biologics EU, significant commercialization agreements (e.g. EirGenix–Sandoz, Prestige–Biosidus), and multiple manufacturing and supply alliances supporting a projected $300B biosimilars market
Company: Alvotech
Product: AVT05
Active Ingredient: Golimumab
Reference Product: Simponi
Reference Product Company: Johnson & Johnson
Disease: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Ulcerative Colitis
Date: Nov 02, 2025
Shots:
- The US FDA has issued a CRL related to the BLA for AVT05, a biosimilar version of Simponi (golimumab), in PFS & autoinjector formulations
- The CRL noted certain deficiencies from the FDA’s Jul 2025 pre-license inspection of Alvotech’s Reykjavik facility that must be resolved before AVT05 BLA approval, though no other issues were found, and the site remains FDA-approved & operational
- Simponi is an IgG1 monoclonal antibody that targets TNF-alpha, resulting in the decrease of inflammatory markers like CRP, IL-6, ICAM-1, MMP-3, & VEGF for treating chronic inflammatory & immune-mediated diseases
Company: Sandoz and Just-Evotec Biologics
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: Nov 04, 2025
Shots:
- Sandoz agreed to acquire Just-Evotec Biologics EU SAS in Toulouse, including its manufacturing site to expand in-house continuous manufacturing for biosimilars, supporting its strategy to capture a projected ~$300B biosimilars market over the next decade
- Sandoz will buy 100% of Just-Evotec Biologics SAS and secure a perpetual license for its continuous manufacturing platform for ~$350M upfront. The deal includes royalties on up to 10 molecules, restructures the partnership, aligning incentives via license fees and development costs, with potential milestones of ~$300M
- The investment fits Sandoz’s current capital plans and does not affect its 2025 guidance
Company: Alvotech and Advanz Pharma
Product: Gobivaz
Active Ingredient: Golimumab
Reference Product: Simponi
Reference Product Company: Johnson & Johnson
Disease: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Ulcerative Colitis
Date: Nov 06, 2025
Shots:
- The UK’s MHRA has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, axial spondylarthritis & ulcerative colitis in adult pts & juvenile idiopathic arthritis, following CHMP’s positive opinion
- Additionally, Alvotech is responsible for the development & commercial supply of Gobivaz, while Advanz Pharma handles registration & holds exclusive commercialization rights in the EU & the UK
- Golimumab is an IgG1 monoclonal antibody that targets TNF-alpha, resulting in the decrease of inflammatory markers like CRP, IL-6, ICAM-1, MMP-3, & VEGF for treating chronic inflammatory & immune-mediated diseases
Company: Samsung Bioepis and Johnson & Johnson
Product: Pyzchiva
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: Nov 06, 2025
Shots:
- Samsung Bioepis has signed a confidential settlement and license agreement with Johnson & Johnson for the commercialization of Pyzchiva, its Stelara (ustekinumab) biosimilar in Europe
- Ustekinumab is an IgG1κ monoclonal antibody targeting IL-12 and IL-23. PYZCHIVA, developed by Samsung Bioepis, received European Commission approval as a Stelara biosimilar in April 2024
- PYZCHIVA was introduced in the EU by Sandoz in July 2024 and expanded to a PFS (autoinjector) in May 2025
Company: EirGenix and Sandoz
Product: EG1206A
Active Ingredient: Pertuzumab
Reference Product: Perjeta
Reference Product Company: Genentech
Disease: HER2-Positive Breast Cancer
Date: Nov 12, 2025
Shots:
- EirGenix has partnered with Sandoz to commercialize EG1206A, a biosimilar to Roche’s Perjeta (Pertuzumab), globally excl. Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, & Japan
- As per the deal, EirGenix will handle product development, manufacturing, & supply, receiving ~$152M in upfront & milestone payments, profit share post-launch in licensed regions, & additional sales-based incentives
- EG1206A has completed its PK study & received positive feedback from the FDA & EMA, granting a waiver for P-III efficacy trials. The partners also have a global deal for EG12014 (150 & 420mg), a biosimilar to Trastuzumab, with BLA under the FDA’s review
Company: Gan & Lee Pharmaceuticals
Product: Ondibta
Active Ingredient: Insulin Glargine Injection
Reference Product: Lantus SoloStar
Reference Product Company: Sanofi
Disease: Diabetes Mellitus
Date: Nov 13, 2025
Shots:
- The CHMP has recommended Ondibta, a biosimilar insulin glargine pre-filled pen for pts (age≥ 2), reference medicine Lantus SoloStar. The EC will now review the opinion, and approval is anticipated across the EU and EEA states
- Insulin glargine is a long-acting, once-daily basal insulin analog that provides up to 24 hours of steady, peakless glucose-lowering activity
- Ondibta completed head-to-head P-III trials in both the EU and the US against Lantus, with studies in over 1,100 pts showing similar efficacy and safety to the reference medicine. The company also confirmed biosimilarity between its insulin glargine U300 and Toujeo through a glucose-clamp PK/PD study
Company: Sandoz
Product: Tyruko
Active Ingredient: Natalizumab
Reference Product: Tysabri
Reference Product Company: Biogen
Disease: Multiple Sclerosis and Crohn’s Disease
Date: Nov 17, 2025
Shots:
- Sandoz has launched Tyruko, a biosimilar version of Biogen’s Tysabri (natalizumab), for all indications of the reference product, incl. relapsing forms of multiple sclerosis (MS) & mod. to sev. active Crohn’s disease in adults
- In 2019, Sandoz signed a global commercialization deal with Polpharma for Tyruko, with Polpharma responsible for development & manufacturing of the drug substance, while Sandoz holds exclusive global commercialization & distribution rights in all markets
- Additionally, Sandoz has partnered with Labcorp to develop & validate a laboratory-developed test for detecting anti-JCV antibodies, & through the Tyruko JCV testing program, Labcorp will offer the test at no cost to eligible pts, with Sandoz covering all expenses
Company: Henlius and Organon
Product: Poherdy
Active Ingredient: Pertuzumab
Reference Product: Perjeta
Reference Product Company: Genentech
Disease: HER2-Positive Breast Cancer
Date: Nov 17, 2025
Shots:
- The US FDA has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product
- Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed similarity & interchangeability in terms of safety, purity, & potency between Poherdy & reference pertuzumab
- In 2022, Henlius granted Organon exclusive global commercialization rights (ex-China) for multiple biosimilars, incl. Poherdy, under a license & supply agreement
Company: Celltrion
Product: Remsima IV
Active Ingredient: Infliximab
Reference Product: Remicade
Reference Product Company: Johnson and Johnson
Disease: Crohn’s Disease, Ulcerative Colitis, Pediatric Crohn’s Disease & Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, and Plaque Psoriasis
Date: Nov 18, 2025
Shots:
- The EC has approved Remsima IV (100mg and 350mg vials), a liquid formulation, a biosimilar version of Remicade
- The approval is supported by data showing the liquid and powder infliximab formulations are comparable in CMC characteristics and stability after reconstitution and dilution
- The Remsima IV liquid formulation is EU-approved for all existing IV infliximab indications, including RA, adult and pediatric CD and UC, AS, PsA, and PsO
Company: Celltrion
Product: Omlyclo
Active Ingredient: Omalizumab
Reference Product: Xolair
Reference Product Company: Genentech and Novartis
Disease: Moderate to severe persistent asthma, Chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and Chronic spontaneous urticaria
Date: Nov 18, 2025
Shots:
- The EC has approved Omlyclo, a biosimilar version of Xolair (omalizumab), in PFS presentation (300 mg/2ml) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU) & chronic rhinosinusitis with nasal polyps (CRSwNP)
- Omlyclo previously received the EC approval in May 2024 for PFS injections at 75mg/0.5mL & 150mg/1mL
- Omalizumab is a humanized mAb that binds free IgE to reduce the release of inflammatory mediators across the allergic cascade in allergic asthma, CSU, & CRSwNP
Company: Accord BioPharma
Product: Osvyrti and Jubereq
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Nov 20, 2025
Shots:
- The US FDA has approved Osvyrti and Jubereq biosimilars to Prolia and Xgeva. Accord is anticipated to commercialize OSVYRTI and JUBEREQ in 2026
- The approvals were supported by a P-I study showing JUBEREQ and Xgeva had comparable PK, and a P-III study in postmenopausal women with osteoporosis demonstrating that OSVYRTI and Prolia are highly similar with no clinically meaningful differences in PK, PD, safety, or efficacy
- Intas has an exclusive deal with Bio-Thera to enable Accord BioPharma to bring the Simponi biosimilar BAT2506 to the US
Company: Alvotech and Advanz Pharma
Product: Gobivaz
Active Ingredient: Golimumab
Reference Product: Simponi
Reference Product Company: Johnson & Johnson
Disease: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Ulcerative Colitis
Date: Nov 20, 2025
Shots:
- The EC has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis (with methotrexate), PsA (± methotrexate), ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis (with methotrexate) across 30 EEA states
- Approval was based on extensive data, incl. P-III trial of AVT05 vs reference Simponi in pts with mod. to sev. rheumatoid arthritis (data reported in Apr 2024) & P-I trial comparing AVT05 to Simponi in healthy adults (reported Nov 2023)
- Additionally, Alvotech is responsible for the development & commercial supply of Gobivaz, while Advanz Pharma handles registration & holds exclusive commercialization rights in the EU
Company: Formycon
Product: Epruvy
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: Nov 20, 2025
Shots:
- Sandoz commercializes Epruvy (Biosimilar, Lucentis) across Germany in PFS and vial forms, following an agreement with Formycon and Bioeq
- Epruvy (ranibizumab)was approved by the EMA in Sep’24 to treat severe visual impairments like nAMD and other retinopathies and is marketed by Sandoz in Germany under a Bioeq license
- Epruvy is available in vials and pre-filled syringes, offering a convenient treatment option in Germany
Company: Klinge Pharma and NTC
Product: FYB203 (Brand Name:Baiama)
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: Nov 24, 2025
Shots:
- Klinge Pharma, holder of global commercialization rights for Formycon’s FYB203, has entered into an exclusive agreement with NTC to commercialize FYB203, a biosimilar version of Eylea (aflibercept), in Italy
- As per the deal, Klinge will receive royalties on net sales, with Formycon participating in these payments in the mid-single to low-double-digit % range, while also serving as the authorized designee to manage FYB203 supply chain & earning additional service payments plus a volume-based profit component for organizing the commercial supply on behalf of Klinge
- FYB203 received the US FDA approval in Jun 2024 & EC approval under brand names Ahzantive & Baiama in Jan 2025, followed by MHRA approval in Feb 2025
Company: Alvotech
Product: AVT03
Active Ingredient: Denosumab
Reference Product: Prolia and Xgeva
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Nov 24, 2025
Shots:
- The EC has approved AVT03, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab), in 60mg/mL PFS (Prolia) & 70mg/mL single-use vial (Xgeva) presentation
- Approval was based on extensive clinical data, incl. analytical, PK & PD data, plus data from AVT03-GL-C01 trial (vs Prolia) among postmenopausal women with osteoporosis, as well as AVT03-GL-P01 trial (vs Prolia) in healthy adult males, depicting similarity in efficacy, safety, immunogenicity & PK b/w the drugs
- In EU, AVT03 will be commercialized by STADA & Dr. Reddy’s, each holding semi-exclusive rights across the EEA, Switzerland & the UK; STADA will market it as Kefdensis/Zvogra, & Dr. Reddy’s as Acvybra/Xbonzy
Company: Teva
Product: Ponlimsi and Degevma
Active Ingredient: Denosumab
Reference Product: Prolia and Xgeva
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Nov 25, 2025
Shots:
- The EC has approved Ponlimsi & Degevma, biosimilar versions of Prolia & Xgeva (denosumab), respectively, following the CHMP positive opinion for bone health treatments
- Approval was based on comprehensive analytical, preclinical, & clinical data, demonstrating comparable quality, safety, & efficacy of Ponlimsi & Degevma to the reference product
- Ponlimsi & Degevma are anti-RANKL monoclonal antibodies that will be available in 60mg/1mL PFS & 120mg/1.7mL vial presentation, respectively
Company: Prestige Biopharma and Biosidus
Product: Tuznue
Active Ingredient: Trastuzumab
Reference Product: Herceptin
Reference Product Company: Roche
Disease: Breast & Gastric Cancers
Date: Nov 25, 2025
Shots:
- Prestige Biopharma has entered into an exclusive license & supply agreement with Biosidus to commercialize Tuznue, a biosimilar version of Herceptin (trastuzumab) across Latin American markets, incl. Argentina, Mexico, Bolivia, & Paraguay
- As per the deal, Biosidus gains exclusive rights to market & distribute Tuznue in Argentina, Mexico, Bolivia & Paraguay, while Prestige Biopharma will be responsible for production & supply of the drug substance, with Biosidus manufacturing the drug product at its facility in Buenos Aires
- Prestige secured EC approval for Tuznue in Sep 2024 for the treatment of HER2+ metastatic & early breast cancer, as well as HER2+ metastatic gastric cancer
Company: Celltrion
Product: Eydenzelt
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: Nov 27, 2025
Shots:
- Health Canada has approved Eydenzelt, a biosimilar version of Eylea (aflibercept 2mg), in both vial & PFS presentation for all the indications of the reference product
- Approval was based on extensive analytical, nonclinical, & clinical data, incl. a global 52wk. P-III trial of Eydenzelt vs Eylea in 348 pts with diabetic macular edema, which met its 1EP of change in best corrected visual acuity at Wk. 8, along with 2EPs of comparable efficacy, safety, & immunogenicity
- Additionally, Eydenzelt, a fusion protein that inhibits VEGF-A & PlGF to reduce neovascularization & vascular leakage in retinal diseases, received EC approval in Feb 2025 & FDA approval in Oct 2025
Related Post: Key Biosimilars Events of October 2025
