Shots:
- Regulatory and launch momentum accelerated globally in late 2025, with multiple FDA approvals, CHMP positive opinions, and EU/US launches for biosimilars referencing blockbuster biologics such as Prolia/Xgeva, Lucentis, Eylea, Xolair, Stelara, Simponi, Neulasta, Humira, Opdivo, and Keytruda—broadening patient access across oncology, immunology, ophthalmology, bone health, and allergy indications
- Leading biosimilar developers including Samsung Bioepis, Celltrion, Alvotech, Formycon, Biocon Biologics, Lupin, STADA, Amneal, Henlius, and Accord Healthcare expanded portfolios and market reach, supported by interchangeability designations, multiple device presentations (PFS, autoinjectors, vials), and synchronized multi-region commercialization strategies
- Strategic licensing, settlement, and commercialization partnerships intensified competition, with deals involving Zydus, Teva, MS Pharma, Valorum, Advanz Pharma, Libbs, and NIPRO, alongside originator settlements with Regeneron, Bayer, and Amgen highlighting a maturing biosimilars market driven by scale, regional expertise, and long-term portfolio diversification
Company: Samsung Bioepis
Product: Obodence & Xbryk
Active Ingredient: Denosumab
Reference Product: Prolia & Xgeva
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Dec 01, 2025
Shots:
- Samsung Bioepis has launched Obodence (60mg PFS) & Xbryk (120mg vial), biosimilar versions of Prolia & Xgeva, for bone health treatments, with commercial availability expected by Dec 2025 & Jan 2026, respectively
- Obodence treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & bone loss in men on hormone ablation for prostate cancer
- Xbryk prevents SREs in adults with bone-involved malignancies, treats giant cell tumors of bone in adults & skeletally mature adolescents with unresectable or high-morbidity tumors
Company: Lupin
Product: Armlupeg
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: Dec 01, 2025
Shots:
- The US FDA has approved Armlupeg (pegfilgrastim-unne) as a biosimilar version of Neulasta (pegfilgrastim)
- Armlupeg (6 mg/0.6 mL) is administered as a single-dose SC injection. It is indicated to reduce the incidence of febrile neutropenia in pts with non-myeloid cancers undergoing myelosuppressive CT and to improve survival following acute myelosuppressive radiation exposure
- Armlupeg will be produced at Lupin’s Biotech facility in Pune, which underwent the US FDA inspection before approval
Company: Accord Healthcare
Product: Osvyrti and Jubereq
Active Ingredient: Denosumab
Reference Product: Prolia & Xgeva
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Dec 02, 2025
Shots:
- Accord Healthcare has launched Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab), following patent expiry of reference products on Nov 27, 2025
- Osvyrti (60mg PFS) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It is also used to treat bone loss in pts on long-term glucocorticoids & prostate cancer pts on hormone ablation
- Jubereq (120mg vial) prevents SREs in adults with bone-involved malignancies & treats giant cell tumors of bone in adults & skeletally mature adolescents, where tumors are unresectable or can lead to severe morbidity upon resection
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: Dec 02, 2025
Shots:
- The CHMP has recommended Samsung Bioepis’ Byooviz (0.5 mg/0.05 ml PFS), a biosimilar version of Lucentis (ranibizumab). The PFS presentation is expected to launch in Q2’26
- BYOOVIZ 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)
- In Oct’25, Samsung Bioepis reported it will assume full commercial responsibility for Byooviz in the EU starting Jan’26
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: Dec 02, 2025
Shots:
- The US FDA has approved Omlyclo, an interchangeable biosimilar version of Xolair (omalizumab), in PFS presentation (300mg/2ml, SC) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps (CRSwNP) & IgE-mediated food allergy
- Omlyclo previously received the US FDA approval in Mar 2025 for PFS injections at 75mg/0.5mL & 150mg/1mL, based on the extensive clinical evidence, showing comparable efficacy & safety between Omlyclo & reference product
- 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: Formycon and MS Pharma
Product: FYB206
Active Ingredient: Pembrolizumab
Reference Product: Keytruda
Reference Product Company: Merck
Disease: All Approved Indications
Date: Dec 04, 2025
Shots:
- Formycon has entered into an exclusive licensing & supply agreement with MS Pharma for the commercialization of Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the MENA region
- As per the deal, Formycon will receive an upfront payment, potential development & regulatory milestones, & a significant share of regional gross profits, though financial terms were not disclosed. The deal also incl. an option for future tech transfer
- FYB206 is a humanized monoclonal antibody against PD-1 receptors that is approaching the end of its clinical development phase, with 1EP results expected in the Q1’26
Company: Lupin and Valorum Biologics
Product: Armlupeg
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: Dec 04, 2025
Shots:
- Lupin has entered into an exclusive licensing agreement with Valorum Biologics for Armlupeg, a biosimilar version of Neulasta (pegfilgrastim)
- As per the deal, Valorum will be responsible for the commercialization and distribution of Armlupeg in the US, while Lupin will handle manufacturing & supply of the product
- In return, Lupin will receive an upfront license fee & royalty payment on net sales, though financial terms remain undisclosed
Company: Formycon and Zydus
Product: FYB206
Active Ingredient: Pembrolizumab
Reference Product: Keytruda
Reference Product Company: Merck
Disease: All Approved Indications
Date: Dec 09, 2025
Shots:
- Formycon has entered into an exclusive licensing & supply agreement with Zydus Lifesciences Global FZE, UAE (Zydus’ subsidiary) for the commercialization of Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the US & Canada
- As per the deal, Formycon will be responsible for development, registration, manufacturing & supply of the drug product, while Zydus Lifesciences Global FZE, UAE will handle its commercialization in the licensed territories
- FYB206 is a humanized monoclonal antibody targeting PD-1 receptors, & its BLA application is expected to be submitted to the US FDA in the near future
Company: Polpharma Biologics and Libbs Farmacêutica
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: Dec 10, 2025
Shots:
- Polpharma Biologics has signed a licensing agreement with Brazil-based Libbs Farmacêutica for an autoimmune biosimilar
- Under this strategic partnership, Polpharma Biologics is fully responsible for the development and manufacturing of the product
- Libbs will exclusively handle the product’s commercialization, marketing, and distribution in the Brazilian market
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: Dec 12, 2025
Shots:
- The CHMP has recommended STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), for EC approval valid in all 30 EEA states
- Opinion was based on extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects, plus P-III trial (vs Simponi) in active PsA pts depicting non-inferior efficacy & comparable PK, safety, & immunogenicity of BAT2506
- In a 2024 deal, STADA obtained exclusive commercial rights to BAT2506 in the EU, UK, Switzerland & selected other countries, while Bio-Thera handled its development, manufacturing, & supply, expanding it later to cover BAT1806 (Biosimilar, RoActemra)
Company: Biocon Biologics, Regeneron, and Bayer
Product: Yesafili
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: Dec 13, 2025
Shots:
- Biocon Biologics has signed a settlement and license agreement with Regeneron and Bayer for Yesafili (Biosimilar, Eylea) in the EU and globally, following a prior US and Canada settlement
- Biocon Biologics, Regeneron, and Bayer settled all pending litigation, allowing Yesafili’s UK launch in Jan’26 and other countries by Mar’26 or earlier. YESAFILI launched in Canada in 2024, and US market entry secured in April 2025, for H2’26 or earlier in certain circumstances
- Yesafili (40mg/ml) is a VEGF inhibitor for treating various eye conditions
Company: Celltrion
Product: Steqeyma
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:Dec 17, 2025
Shots:
- The CHMP has recommended Steqeyma autoinjector (45mg/0.5mL & 90mg/1mL), a biosimilar version of Stelara (ustekinumab), for the treatment of pts with plaque psoriasis, psoriatic arthritis (PsA) & Crohn’s disease (CD)
- SteQeyma (CT-P43) is a human anti-IL-12 & IL-23 monoclonal antibody that is also available in SC formulation (45mg/0.5mL or 90mg/1mL in PFS & prefilled pen as well as 45mg/0.5 in vial) & IV infusion (130mg/26mL)
- Steqeyma is licensed in 40+ countries, incl. the US, Japan & EU, with its citrate-free autoinjector presentation featuring thin-wall needle technology to reduce injection pain
Company: Lupin
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: Dec 17, 2025
Shots:
- The CHMP has recommended marketing authorization for Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab)
- Opinion was supported by analytical similarity data and a global P-III trial (n=600 pts) in neovascular AMD across the US, EU, Russia, and India
- Under the agreement, Lupin’s biosimilar ranibizumab will be marketed by Sandoz across the EU (excluding Germany), with Sandoz AG and Biogaran commercializing it in France
Company: Alvotech, Teva, and Regeneron
Product: AVT06
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: Dec 19, 2025
Shots:
- Alvotech and Teva reached a settlement and license agreement with Regeneron, allowing the US launch of AVT06, a biosimilar version of Eylea (aflibercept) in Q4’26 or earlier under certain conditions
- AVT06 is an aflibercept (Eylea) biosimilar that inhibits VEGF and has been approved as Mynzepli in the UK and EEA and as Aflibercept BS in Japan
- On Jan’24, Alvotech reported positive topline results showing AVT06 met its 1EP and demonstrated high similarity to Eylea in pts with wet AMD
Company: Shanghai Henlius
Product: HLX18
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: Dec 19, 2025
Shots:
- The US FDA has granted IND clearance to HLX18 (nivolumab), a biosimilar version of Opdivo, for the treatment of certain resected solid tumors
- Novolumab is an 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
- HLX17 (pembrolizumab biosimilar) and HLX13 (ipilimumab biosimilar) have entered worldwide multicenter P-I studies with initial patient dosing completed. HLX18 (nivolumab biosimilar) is being evaluated across multiple solid tumor indications
Company: Alvotech
Product: Gobivaz
Active Ingredient: Golimumab
Reference Product: Simponi
Reference Product Company: Johnson & Johnson
Disease: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Ulcerative Colitis
Date: Dec 22, 2025
Shots:
- Alvotech has reported the launch of Gobivaz (AVT05), a biosimilar version of Simponi (golimumab) for the treatment of several chronic inflammatory diseases, with commercialization led by Advanz Pharma
- In the UK, Gobivaz’s launch is supported by an NHS England tender award, while rollout across EEA markets will advance in line with country-specific pricing, reimbursement & market access processes; it is offered in identical dosage forms & presentations & manufactured at Alvotech’s Iceland facility
- Gobivaz is an IgG1 anti-TNF-α monoclonal antibody that received EC approval supported by robust analytical, preclinical & clinical data demonstrating biosimilarity to Simponi
Company: Amneal Pharmaceuticals and mAbxience
Product: Boncresa and Oziltus
Active Ingredient: Denosumab
Reference Product: Prolia and Xgeva
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Dec 22, 2025
Shots:
- The US FDA has approved Boncresa (denosumab-mobz), a biosimilar version of Prolia, and Oziltus (denosumab-mobz), a biosimilar version of Xgeva
- Denosumab is an mAb that reduces bone resorption and is used in oncology and osteoporosis indications
- Under the Amneal and mAbxience collaboration, mAbxience manages development and manufacturing, and Amneal has exclusive US commercialization rights
Company: Biocon Biologics and Yowa Kirin Biologics
Product: Hulio
Active Ingredient: Adalimumab
Reference Product: Humira
Reference Product Company: Abbvie
Disease: Mod. to Sev. Active Rheumatoid arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Ulcerative Colitis, Chronic Plaque Psoriasis, Hidradenitis Suppurativa, and Uveitis
Date: Dec 23, 2025
Shots:
- Biocon Biologics secured full global rights to Hulio (Adalimumab), a biosimilar of adalimumab, from Fujifilm Kyowa Kirin Biologics
- As per the agreement, Biocon Biologics will take full responsibility for manufacturing, commercialization, and further development, while FKB will support development, offset certain development costs, and receive technology license fees and royalties for a specified tenure
- Biocon Biologics gained adalimumab biosimilar rights in 2022 through the Viatris biosimilars business acquisition
Product: Nufymco
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: Dec 23, 2025
Shots:
- The US FDA has approved Nufymco (ranibizumab-leyk), an interchangeable biosimilar of Lucentis, with Zydus serving as its commercialization partner in the US
- Nufymco is an interchangeable Lucentis biosimilar developed by Formycon, approved for the treatment of wet AMD, diabetic macular edema, diabetic retinopathy, retinal vein occlusion-related macular edema, and myopic choroidal neovascularization
- Zydus secured exclusive US and Canada rights to Formycon’s Keytruda biosimilar FYB206
Company: Samsung Bioepis
Product: Ustekinumab BS
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: Dec 23, 2025
Shots:
- Samsung Bioepis has received Japanese marketing approval for Ustekinumab BS 45mg syringes, a biosimilar of Stelara, under its partnership with NIPRO Corporation
- Ustekinumab, a human IgG1κ antibody targeting IL-12/IL-23, is approved in Japan as ‘NIPRO’ for plaque psoriasis and psoriatic arthritis, with NHI listing expected in May 2026
- It is also approved in Australia, Brazil, Canada, Europe, Korea, Switzerland, the UK, and the US
Company: Mabwell
Product: Adalimumab Injection 9MW0113
Active Ingredient: Adalimumab
Reference Product: Humira
Reference Product Company: Abbvie
Disease: Mod. to Sev. Active Rheumatoid arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Ulcerative Colitis, Chronic Plaque Psoriasis, Hidradenitis Suppurativa, and Uveitis
Date: Dec 31, 2025
Shots:
- Mabwell’s Adalimumab Injection 9MW0113 (marketed as JUNMAIKANG in China), a Humira biosimilar, has received marketing authorization from Indonesia’s BPOM
- Adalimumab Injection 9MW0113, co-developed by Mabwell and Junshi Biosciences. Mabwell has submitted registration applications in multiple countries, including Jordan and Peru, and has agreements in over ten markets
- Adalimumab is a TNF blocker, binds TNF‑alpha and prevents it from interacting with p55 and p75 TNF receptors, used to treat various autoimmune conditions
Related Post: Key Biosimilars Events of November 2025
