Shots:
- Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
- Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients
- Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the US. Our team at PharmaShots has summarized 15 key events of the biosimilar space of July 2025
Company: Fresenius Kabi
Product: Conexxence and Bomyntra
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Jul 01, 2025
Shots:
- Fresenius Kabi launched Conexxence and Bomyntra, biosimilar of Prolia & Xgeva (denosumab) for all indications of the reference products across the US
- Conexxence (denosumab-bnht) 60 mg/mL, available in PFS, is approved for adults at high risk of fractures, including those with osteoporosis, pts. on cancer treatments affecting bone density, or long-term glucocorticoids
- Bomyntra (denosumab-bnht) 120 mg/1.7 mL, available in a vial and a PFS, is approved to prevent skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors
Company: Bio Usawa Biotechnology and Bioeq AG
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: Jul 01, 2025
Shots:
- Bio Usawa Biotechnology and Bioeq AG entered into an agreement to make ranibizumab biosimilar for serious retinal diseases, accessible to millions in Sub-Saharan Africa
- The partnership gives Bio Usawa exclusive rights to register and market Bioeq’s ranibizumab biosimilar, BioUcenta, advancing access to essential biologics in Sub-Saharan Africa
- BioUcenta, an intravitreal injection, blocks abnormal retinal blood vessel growth and fluid leakage—major causes of vision loss. Approved in EU and the US, it will now be registered and distributed in Sub-Saharan Africa by Bio Usawa
Company: Alvotech & Advanz Pharma
Product: AVT10
Active Ingredient: Certolizumab Pegol
Reference Product: Cimzia
Reference Product Company: UCB
Disease: Crohn’s disease, mod. to sev. active rheumatoid arthritis & plaque psoriasis, active polyarticular juvenile idiopathic arthritis (pJIA), active psoriatic arthritis, active ankylosing spondylitis, and active non-radiographic axial spondyloarthritis
Date: Jul 01, 2025
Shots:
- Alvotech has entered into a supply & commercialization agreement with Advanz Pharma for AVT10, a biosimilar version of Cimzia (certolizumab pegol)
- Alvotech & Advanz Pharma have previously partnered on biosimilars for over 10 reference biologics, with a plan to launch their first biosimilars in the EU by Q4’25
- Cimzia binds with both soluble & membrane-bound TNF-alpha to block its inflammatory signaling without triggering complement or antibody-dependent cytotoxicity due to the lack of its Fc region
Company: Apotex
Product: Aflivu
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: Jul 02, 2025
Shots:
- Apotex has reported Health Canada’s approval of Aflivu (aflibercept), a biosimilar to Eylea in PFS and vials
- Aflivu is indicated for wet age-related macular degeneration, macular edema from retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization
- Aflivu expands Apotex’s biosimilar portfolio, which already includes Grastofil (filgrastim), Lapelga (pegfilgrastim), and Bambevi (bevacizumab)
Company: mAbxience
Product: Denbrayce and Izamby
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Jul 02, 2025
Shots:
- The EC has approved Denbrayce & Izamby, biosimilar of Amgen’s Xgeva & Prolia (denosumab) following the CHMP’s recommendation
- Denbrayce prevents skeletal-related events in adults with bone-involved malignancies & treats giant cell tumors of bone in adults & skeletally mature adolescents
- Izamby is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures
Company: Biocon Biologics
Product: Vevzuo and Evfraxy
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Jul 03, 2025
Shots:
- EC has approved Vevzuo & Evfraxy, biosimilar of Amgen’s Xgeva & Prolia (denosumab) following the CHMP positive opinion in Apr 2025
- Approval was based on the comprehensive clinical data, which showed comparable PK, safety, efficacy & immunogenicity of Vevzuo & Evfraxy to the reference product
- Vevzuo prevents SREs in adults with bone-involved malignancies & treats unresectable or high-morbidity giant cell tumors of bone in adults & skeletally mature adolescents, while Evfraxy treats osteoporosis in postmenopausal women & men at high risk of fracture, & bone loss in pts on long-term glucocorticoids as well as in prostate cancer pts on hormone ablation
Company: CuraTeQ Biologics
Product: Dazublys
Active Ingredient: Trastuzumab
Reference Product: Herceptin
Reference Product Company: Roche
Disease: Breast & Gastric Cancers
Date: Jul 04, 2025
Shots:
- CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EC’s approval of Dazublys, its trastuzumab biosimilar following the CHMP’s recommendation in Apr 2025
- The approval was based on its demonstrated similarity to Herceptin in PK, PD, efficacy, safety, and immunogenicity
- Dazublys is approved for HER2-positive breast and gastric cancers, and expanding access to treatment across the EU
Company: Celltrion
Product: Osenvelt and Stoboclo
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Jul 07, 2025
Shots:
- Celltrion has launched Osenvelt & Stoboclo, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) in the US
- Stoboclo (60mg/mL) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer & women on adjuvant aromatase inhibitors for breast cancer
- Osenvelt (120mg/1.7mL) prevents SREs in adults with bone-involved malignancies & MM, treats giant cell tumors of bone in adults & skeletally mature adolescents with unresectable or high-morbidity tumors, & manages hypercalcemia of malignancy refractory to bisphosphonate therapy
Company: Lupin & Zentiva
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: Jul 09, 2025
Shots:
- Zentiva has entered into a license & supply agreement with Lupin to commercialize Lupin’s TNF-alpha inhibitor biosimilar across multiple global markets
- Zentiva will lead commercialization outside the US & Canada, mainly in EU & CIS, while Lupin will handle development, manufacturing, & supply in agreed territories & commercialization in the remaining territories, incl. the US & Canada
- As per the deal, Lupin will receive a $10M upfront & ~$50M in development & regulatory milestones, with both companies sharing profits from defined markets. Also, both parties will invest in the biosimilar’s development
Company: Biocon Biologics
Product: Kirsty
Active Ingredient: Insulin Aspart
Reference Product: NovoLog
Reference Product Company: Novo Nordisk
Disease: Diabetes Mellitus
Date: Jul 15, 2025
Shots:
- The US FDA has approved Kirsty (100 units/mL), an interchangeable biosimilar of NovoLog (Insulin Aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus
- Approval was based on comprehensive analytical, non-clinical, & clinical data, which showed similar efficacy, safety, purity & potency of Kirsty vs NovoLog
- Kirsty is a rapid-acting human insulin analog that will be available as a prefilled pen for SC use as well as a vial for both SC & IV use
Company: Bio-Thera
Product: BAT2506
Active Ingredient: Golimumab
Reference Product: Simponi
Reference Product Company: Johnson & Johnson
Disease: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, and Ulcerative Colitis
Date: Jul 16, 2025
Shots:
- FDA has accepted BLA for BAT2506, a biosimilar of Simponi (golimumab) for all approved doses, formulations, & indications of reference product, with a request for interchangeability (BsUFA: May 16, 2026)
- BLA was backed by extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects, plus P-III trial (vs EU Simponi) in active PsA pts depicting non-inferior efficacy & comparable PK, safety, & immunogenicity of BAT2506
- Accord BioPharma (Intas’ US division) submitted the BLA for BAT2506 & will be the MA holder under a Feb 2025 Deal with Bio-Thera, which will handle development & manufacturing of BAT2506, while Accord will lead US commercialization
Company: Samsung Bioepis & Harrow
Product: Byooviz & Opuviz
Active Ingredient: Ranibizumab & Aflibercept
Reference Product: Lucentis & Eylea
Reference Product Company: Genentech & Bayer
Disease: Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy, Retinopathy of Prematurity and Myopic Choroidal Neovascularization
Date: Jul 17, 2025
Shots:
- Samsung Bioepis has entered into a definitive agreement to grant Harrow exclusive commercial rights of its ophthalmology biosimilar portfolio incl. Byooviz, biosimilar to Lucentis (ranibizumab), & Opuviz, biosimilar to Eylea (aflibercept) in the US
- Byooviz has been available in the US through Biogen since its launch in Jun 2022. In Oct 2024, Biogen notified Samsung Bioepis of its decision to end their 2019 Deal in the US & Canada, & both companies are working on transferring commercialization rights for Byooviz & Opuviz back to Samsung Bioepis
- Harrow will handle US commercialization of Byooviz after the transfer of rights to Samsung Bioepis, which is expected to be completed by the end of 2025
Company: Fresenius
Product: Conexxence and Bomyntra
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Jul 23, 2025
Shots:
- The EC has approved Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab)
- Approval covers all indications of the reference products incl. osteoporosis in postmenopausal women & men at high risk of fracture, SRE prevention in adults with bone-involved malignancies, giant cell tumors of bone & treatment-related bone loss
- Additionally, Fresenius & Amgen reached a global settlement in Mar 2025, allowing the US launch of these biosimilars in mid-2025 & their European launch in late H2’25
Company: Henlius
Product: HLX14
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Jul 28, 2025
Shots:
- The CHMP has recommended approval of HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab) for all indications of the reference product; review is ongoing in the US, Canada & other regions
- Opinion was based on multiple H2H trials, incl. analytical & clinical studies, which showed similar quality, efficacy & safety of HLX14 vs denosumab
- Additionally, Henlius received a GMP certificate from Belgium’s FAMHP for production lines related to HLX14 & another product, plus in 2022, it licensed Organon exclusive rights to 2 biosimilars, incl. HLX11, for the US, EU, & Canada (excl. China)
Company: Alteogen
Product: Eyluxvi
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: Jul 28, 2025
Shots:
- The CHMP has recommended Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation
- Opinion was based on extensive analytical, non-clinical, & clinical data incl. a P-III trial assessing ALT-L9 (n = 216) vs Eylea (n = 215) in 431 wet AMD pts, which showed similar efficacy, safety, immunogenicity, & PK between the two
- Eyluxvi is a fusion protein that blocks VEGF-A & PIGF from binding to VEGFR-1/2 to reduce neovascularization & vascular permeability, thereby slowing vision loss in retinal diseases
Related Post: Key Biosimilars Events of June 2025
