Shots:
- Biosimilars are developed to match approved biologic therapies in safety, and efficacy, ensuring comparable clinical outcomes. They represent a critical pathway to reducing healthcare costs by providing affordable alternatives to expensive branded biologics, delivering meaningful savings for both patients and payers
- In a key development, Henlius and Organon secured U.S. FDA approval for Bildyos and Bilprevda, biosimilars to Prolia and Xgeva
- PharmaShots has captured and summarized 18 major biosimilar milestones from September 2025, highlighting the continued momentum in this rapidly evolving segment of the biopharma landscape.
Company: Henlius and Organon
Product: Bildyos & Bilprevda
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Sep 02, 2025
Shots:
- The US FDA has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product
- Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable quality, efficacy & safety of Bildyos & Bilprevda to reference denosumab
- In 2022, Henlius granted Organon exclusive global commercialization rights (ex-China) for multiple biosimilars, incl. Bildyos & Bilprevda, under a license & supply agreement
Company: Polpharma Biologics and MS Pharma
Product: PB016, PB018, & PB019
Active Ingredient: Vedolizumab, Ocrelizumab, and Guselkumab
Reference Product: Entyvio, Ocrevus, and Tremfya
Reference Product Company: Takeda, Genentech, and Johnson & Johnson
Disease: For All Approved Indications
Date: Sep 02, 2025
Shots:
- Polpharma has entered into licensing deals with MS Pharma to commercialize PB016 (vedolizumab), PB018 (ocrelizumab), & PB019 (guselkumab) biosimilars across the Middle East & North Africa (MENA) region
- As per the deal, MS Pharma will be responsible for registration, marketing, & distribution of the 3 biosimilars in MENA, while Polpharma will handle development, manufacturing, & supply; fill-finish activities to be transferred to MS’ biologics facility in Saudi Arabia
- Vedolizumab targets α4β7 integrin to treat UC & Crohn’s disease, while ocrelizumab depletes CD20+ B cells to reduce inflammation in multiple sclerosis. Guselkumab blocks IL-23 (p19 subunit) & is approved for plaque PsO & PsA
Company: Kashiv BioSciences and CRISTÁLIA
Product: ADL-018
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: Sep 11, 2025
Shots:
- Kashiv BioSciences has entered into a licensing & supply agreement with CRISTÁLIA for the commercialization of ADL-018, a biosimilar version of Xolair (omalizumab) in Latin America
- As per the deal, CRISTÁLIA will handle licensing, distribution, & commercialization of ADL-018 in the LATAM region, while Kashiv BioSciences will be responsible for the development within the agreed territories
- ADL-018 is a mAb targeting IgE. Xolair is approved for treating Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU), severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), & IgE-mediated food allergy
Company: Bio-Thera Solutions and Jamjoom Pharmaceuticals
Product: BAT2306
Active Ingredient: Secukinumab
Reference Product: Cosentyx
Reference Product Company: Novartis
Disease: Mod. to sev. Plaque Psoriasis & Hidradenitis Suppurativa, Active Psoriatic Arthritis, Active Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, and Active Enthesitis-related Arthritis
Date: Sep 15, 2025
Shots:
- Bio-Thera Solutions & Jamjoom Pharmaceuticals have entered into a strategic agreement to commercialize BAT2306, a biosimilar version of Novartis’ Cosentyx (secukinumab) in the Middle East & Africa (MENA)
- As per the deal, Jamjoom will obtain exclusive MENA rights of BAT2306 to handle regulatory submissions, market access & commercialization, while Bio-Thera will be responsible for development & global manufacturing from its Guangzhou, China facility
- Secukinumab is a fully human IgG1/κ monoclonal antibody targeting IL-17A, which blocks this proinflammatory cytokine to inhibit pathways driving chronic immune-mediated conditions like plaque PsO
Company: Formycon and Klinge Biopharma
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: Sep 17, 2025
Shots:
- Formycon and Klinge Biopharma have signed a semi-exclusive licensing deal with Horus Pharma to commercialize the FYB203/Baiama (Biosimilar, Eylea) in selected EC, following a similar agreement with Teva in Jan for covering major parts of the EU & Israel
- Klinge will receive upfront, milestone payments, and royalties on net sales, with Formycon earning a share (mid-single to low-double-digit %) of all payments. Formycon will also manage the FYB203 supply chain and receive service fees and volume-based profit for commercial supply
- Aflibercept treats neovascular age-related macular degeneration (nAMD) and other serious retinal diseases, a leading cause of blindness in people over 60 in EU and North America
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: Sep 17, 2025
Shots:
- The EC has approved 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
- Approval was based on P-III trials conducted across the EU, South Korea, & Japan, incl. a trial assessing Eyluxvi vs Eylea in 431 wet AMD pts, which showed similar efficacy & safety 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
Company: Biocon Biologics
Product: Aukelso and Bosaya
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Sep 17, 2025
Shots:
- The US FDA has approved & granted provisional interchangeability designation to Aukelso (70mg/mL, SC, single-dose vial) & Bosaya (60mg/mL, SC, PFS), biosimilar versions of Amgen’s Xgeva & Prolia (denosumab)
- Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya was approved with Prolia’s REMS to inform about sev. hypocalcemia risk in advanced CKD, incl. dialysis
- Denosumab is a mAb that works by targeting Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL), which regulates bone metabolism & osteoclast formation
Company: Celltrion
Product: Stoboclo and Osenvelt
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Sep 18, 2025
Shots:
- Health Canada has approved Stoboclo & Osenvelt (CT-P41), referencing biosimilar Prolia & Xgeva, for all approved indications of the reference drugs
- Approval was supported by P-III trial data in postmenopausal women with osteoporosis (PMO), showing CT-P41 matched reference denosumab in efficacy & PD, with similar PK, safety, and immunogenicity
- Stoboclo and Osenvelt are RANKL inhibitors developed as biosimilars to Prolia and Xgeva, respectively, for regulating bone metabolism
Company: STADA
Product: Kefdensis and Zvogra
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Sep 19, 2025
Shots:
- The CHMP has recommended Kefdensis and Zvogra, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders
- Kefdensis (biosimilar to Prolia) received CHMP approval for treating osteoporosis in high-risk postmenopausal women and men with an increased risk of fractures. Zvogra (biosimilar to Xgeva) received CHMP approval for preventing skeletal events in adults with bone-involved cancers and for treating unresectable giant cell bone tumors
- Under their strategic partnership, Alvotech develops and manufactures denosumab biosimilars (AVT03) in Iceland, while STADA will hold marketing rights in EU, Central Asia, and the Middle East upon EU approval. The companies previously partnered on biosimilars for adalimumab and ustekinumab in EU
Company: Alvotech
Product: AVT03, AVT05, and AVT06
Active Ingredient: Denosumab, Golimumab, and Aflibercept
Reference Product: Xgeva (Ranmark), Simponi, and Eylea
Reference Product Company: Amgen, Johnson & Johnson, and Bayer
Disease: For All Approved Indications
Date: Sep 19, 2025
Shots:
- Alvotech has reported that its partner Fuji Pharma has received Japanese approval for three biosimilars: AVT03 (Biosimilar, Ranmark), AVT05 (Biosimilar, Simponi), and AVT06 (Biosimilar, Eylea)
- In Japan, AVT03 (denosumab-biosimilar to Ranmark/Xgeva) was approved for bone lesions from multiple myeloma or solid tumor metastases; AVT05 (golimumab biosimilar to Simponi) for rheumatoid arthritis Pts. who are unresponsive to conventional treatments; and AVT06 (aflibercept biosimilar to Eylea) for AMD, macular edema from retinal vein occlusion, and myopic CNV
- Alvotech and Fuji Pharma’s partnership, established in 2018, now includes four approved biosimilars and two additional candidates under development, which are licensed to Fuji Pharma
Company: CuraTeQ Biologics
Product: Denosumab
Active Ingredient: Denosumab
Reference Product: Prolia
Reference Product Company: Amgen
Disease: postmenopausal Osteoporosis
Date: Sep 19, 2025
Shots:
- CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported positive P-III results for its denosumab biosimilar targeting postmenopausal osteoporosis, as an alternative to Prolia
- The study involved 446 postmenopausal women across 40 sites in EU met all EPs, showing no significant differences between the biosimilar and Prolia
- The trial confirmed the biosimilar’s efficacy in improving bone density and reducing fracture risk. It met the 1EP (LS-BMD % change at Wk. 52 within -1.45 to +1.45) and co-primary EP (sCTX AUEC from Wk. 0 to Wk. 26 within 0.80–1.25), meeting FDA and EMA criteria
Company: Henlius and Organon
Product: Bildyos & Bilprevda
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Sep 19, 2025
Shots:
- The EC has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product
- Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable immunogenicity, efficacy & safety of Bildyos & Bilprevda to reference denosumab
- In 2022, Henlius granted Organon exclusive global commercialization rights (ex-China) for multiple biosimilars, incl. Bildyos & Bilprevda, under a license & supply agreement
Company: Alkem Laboratories
Product: Pertuza
Active Ingredient: Pertuzumab
Reference Product: Perjeta
Reference Product Company: Genentech
Disease: HER2-Positive Breast Cancer
Date: Sep 22, 2025
Shots:
- Alkem Laboratories has launched Pertuza 420mg/14mL, a Perjeta biosimilar, across India for treating HER2-positive breast cancer
- In a P-III trial, Pertuza showed equivalent efficacy, safety, and immunogenicity to the reference product
- Pertuzumab is a HER2/neu receptor antagonist that was approved for HER2-positive breast cancer
Company: Alvotech
Product: AVT03
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Sep 22, 2025
Shots:
- The CHMP has recommended AVT03, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders
- STADA & Dr. Reddy’s have semi-exclusive commercial rights to AVT03 in the EU, incl. Switzerland & the UK, leading to STADA marketing it as Kefdensis (Prolia; 60mg/mL PFS) & Zvogra (Xgeva; 70mg/mL single-use vial), while Dr. Reddy’s will offer Acvybra (60mg/mL PFS) & Xbonzy (70mg/mL vial)
- Denosumab is a mAb that works by targeting Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL), which regulates bone metabolism & osteoclast formation
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: Sep 22, 2025
Shots:
- The CHMP has recommended Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis across 30 EEA states
- In trials, Gobivaz demonstrated comparable efficacy, safety, & immunogenicity to Simponi in pts with mod. to sev. rheumatoid arthritis (reported Apr 2024), & similar PK, safety, & tolerability 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: Kashiv BioSciences and JAMP Pharma
Product: Pexegra and Filra
Active Ingredient: Pegfilgrastim and Filgrastim
Reference Product: Neulasta and 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: Sep 24, 2025
Shots:
- Kashiv BioSciences & JAMP Pharma have launched Pexegra & Filra, biosimilar version of Neulasta & Neupogen, respectively, in Canada
- JAMP Pharma & Kashiv BioSciences entered an exclusive agreement to market Pexegra & Filra in Canada, with Kashiv’s facilities supporting JAMP’s commercialization efforts
- Pexegra (6mg/0.6mL) & Filra (300mcg/0.5mL & 480mcg/0.8mL) help treat CT-induced neutropenia by boosting neutrophils for fighting infection
Company: Amneal Pharmaceuticals
Product: Omalizumab
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: Sep 26, 2025
Shots:
- The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciences
- Additionally, Amneal expects to incur a $22.5M R&D milestone charge in Q3’25 instead of Q4 due to the earlier BLA filing & holds exclusive US commercialization rights for the product pending regulatory approval
- Xolair is a humanized mAb designed to block IgE binding to FcεRI on mast cells & basophils for the treatment of mod. to sev. persistent asthma (pts: ≥6yrs.), CRSwNP (≥18yrs.), food allergies (≥1yr.), & chronic spontaneous urticaria (≥12yrs.)
Company: Gedeon Richter and Hikma Pharmaceuticals
Product: Enoby and Xtrenbo
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Sep 29, 2025
Shots:
- The US FDA has approved Enoby (RGB-14-P) & Xtrenbo (RGB-14-X), biosimilar versions of Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders
- Approval was based on extensive clinical data submitted by Hikma, incl. analytical, non-clinical & clinical studies, which showed comparable quality, efficacy, safety & immunogenicity of Enoby & Xtrenbo to reference denosumab
- Hikma & Richter entered a license & commercialization deal in Dec 2021, with Richter handling product development & manufacturing, while Hikma manages FDA registration & holds exclusive US commercialization rights
Note: The following biosimilar received the CHMP’s Positive Opinion. However, as of September 30, 2025, no PR was available:
- Usgena (Biosimilar, Ustekinumab)
- Degevma (Biosimilar, Denosumab)
- Ponlimsi (Biosimilar, Denosumab)
Related Post: Key Biosimilars Events of August 2025
