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, Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives the US FDA’s Approval to Treat Multiple Retinal Diseases
- PharmaShots has captured and summarized 17 major biosimilar milestones from September 2025, highlighting the continued momentum in this rapidly evolving segment of the biopharma landscape.
Company: Biocon Biologics
Product: Bosaya and Aukelso
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Oct 01, 2025
Shots:
- Biocon Biologics & Amgen have entered into a settlement & license agreement, allowing the US launch of Bosaya (60mg/mL, SC, PFS) & Aukelso (70mg/mL, SC, single-dose vial), provisional interchangeable biosimilars to Prolia & Xgeva (denosumab) by Oct 1, 2025
- 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 RANKL, which regulates bone metabolism & osteoclast formation
Company: Celltrion
Product: Avtozma
Active Ingredient: Tocilizumab
Reference Product: Actemra
Reference Product Company: Genentech
Disease: Rheumatoid Arthritis, Giant Cell Arteritis, Systemic Sclerosis-Associated Interstitial Lung Disease, Polyarticular Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis, Cytokine Release Syndrome, and COVID-19
Date: Oct 03, 2025
Shots:
- Celltrion has launched Avtozma IV, a biosimilar to Actemra (tocilizumab) for all the approved indications of the reference product in the US
- In Jan 2025, the FDA approved Avtozma based on a global P-III trial showing comparable efficacy, PK, safety & immunogenicity vs reference tocilizumab, followed by an additional July 2025 FDA approval for its IV formulation to treat pts (≥2yrs.) with cytokine release syndrome
- Avtozma IV is a recombinant humanized mAb that targets the IL-6 receptor & is available in 80mg/4mL, 200mg/10mL, & 400mg/20mL (20 mg/mL) in single-dose vials
Company: Kashiv Biosciences
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: Oct 06, 2025
Shots:
- Kashiv BioSciences submitted a BLA to the US FDA and received EMA MAA acceptance for ADL-018, a proposed biosimilar to Xolair (omalizumab)
- ADL-018 is a humanized mAb biosimilar to Xolair (omalizumab), designed to block IgE binding on mast cells and basophils. Xolair is approved for CSU (≥12 yrs), moderate-to-severe asthma (≥6 yrs), chronic rhinosinusitis with nasal polyps (≥18 yrs), and IgE-mediated food allergy (≥1 yr)
- Alvotech partnered with Kashiv BioSciences to develop the proposed Xolair biosimilar known as AVT23 by Alvotech and ADL-018 by Kashiv for markets including the EEA, UK, Switzerland, Australia, New Zealand, and Canada
Company: Alvotech and Advanz Pharma
Product: AVT23
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: Oct 06, 2025
Shots:
- The EMA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab), following the MHRA’s MAA acceptance earlier this year
- AVT23 was jointly developed by Alvotech & Kashiv BioSciences, with Advanz Pharma obtaining commercial rights to AVT23 in the EEA, UK, Switzerland, Canada, Australia and New Zealand
- Omalizumab is a humanized mAb that binds to free IgE to produce an anti-inflammatory action in allergic asthma, chronic spontaneous urticaria, & CRSwNP
Company: Hikma and Celltrion
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: Allergic Diseases, Ophthalmology, Skeletal-related Disorders, Immune Diseases & Oncology
Date: Oct 06, 2025
Shots:
- Hikma Pharmaceuticals & Celltrion have entered into exclusive licensing agreements for various biosimilar candidates across the Middle East & North Africa (MENA) region, expanding their previous partnerships
- The agreement will include the commercialization of 6 biosimilars to expand access across multiple therapeutic areas, incl. allergic diseases, ophthalmology, skeletal-related disorders, immune diseases & oncology
- As per the deal, Hikma will receive exclusive rights to commercialize the 6 biosimilars across all MENA regions, with Celltrion handling development, manufacturing & supply of the therapies
Company: Bio-Thera and Intas Pharmaceuticals
Product: BAT2506
Active Ingredient: Golimumab
Reference Product: Simponi
Reference Product Company: Johnson & Johnson
Disease: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Ulcerative Colitis
Date: Oct 09, 2025
Shots:
- Bio-Thera Solutions has entered into an exclusive commercialization & license agreement with Intas Pharmaceuticals for BAT2506, a biosimilar version of Simponi (golimumab), for Canada
- The agreement expands their Feb 2025 deal, under which Intas holds US commercialization rights for BAT2506, while Bio-Thera handles its development & manufacturing
- BAT2506 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: 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: Oct 10, 2025
Shots:
- The US FDA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept), to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), & diabetic retinopathy
- Approval was supported by extensive analytical, non-clinical, & clinical data, incl. a P-III trial in DME pts (n=348) comparing Eydenzelt vs Eylea over 52wks., which met its 1EP of change in best corrected visual acuity at Wk. 8, along with 2EPs of comparable efficacy, safety, & immunogenicity
- Eydenzelt is a fusion protein that blocks VEGF-A & PIGF to reduce neovascularization & vascular permeability, thereby slowing vision loss in retinal diseases
Company: Biocon Biologics and Civica
Product: Insulin Glargine
Active Ingredient: Insulin Glargine
Reference Product: Lantus
Reference Product Company: Sanofi
Disease: Diabetes Mellitus
Date: Oct 16, 2025
Shots:
- Biocon Biologics has expanded its strategic collaboration with Civica to commercialize Insulin Glargine in the US
- Biocon Biologics & Civica entered into a multi-year exclusive distributorship where Biocon will manufacture & supply Insulin Glargine, & Civica will handle its commercialization in the US under its own label, incl. the CalRx brand in California
- No technology transfer is involved, & Biocon Biologics will retain IP, marketing rights, & will continue to directly commercialize its FDA-approved interchangeable biosimilar Insulin Glargine-yfgn
Company: Formycon, Actor Pharmaceuticals and Megalabs
Product: FYB203
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: Oct 16, 2025
Shots:
- Formycon has reported that Klinge Biopharma, holder of global rights to its FYB203 (biosimilar, Eylea), has granted exclusive commercialization rights to Actor Pharmaceuticals for Australia and to Megalabs for LATAM. Regulatory filing is submitted to Australia’s TGA, and Formycon is preparing approval applications with Megalabs for LATAM
- As per the deal, Klinge will receive upfront and milestone payments, plus royalties, with Formycon sharing in these payments (in the mid-single- to low-double-digit range). Formycon will also manage FYB203 supply and earn service fees and a volume-based profit share
- Eylea (aflibercept) treats nAMD and other retinal diseases by inhibiting VEGF-driven abnormal blood vessel growth
Company: Celltrion
Product: Yuflyma
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: Oct 17, 2025
Shots:
- The US FDA has approved Yuflyma, a biosimilar version of Humira (adalimumab) & its unbranded version for the treatment of HS in adolescents (≥12yrs.), & uveitis in children (≥2yrs.)
- Yuflyma, an anti-TNFα mAb, was previously approved by the FDA for rheumatoid & psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, & plaque psoriasis, as well as for adults with HS & uveitis
- Yuflyma (interchangeable biosimilar) was launched in the US in Jul 2023 & is available in prefilled syringes (20mg/0.2mL, 40mg/0.4mL & 80mg/0.8mL) & autoinjectors (40mg/0.4mL & 80mg/0.8mL)
Company: Teva and Prestige Biopharma
Product: Tuznue
Active Ingredient: Trastuzumab
Reference Product: Herceptin
Reference Product Company: Roche
Disease: Breast & Gastric Cancers
Date: Oct 20, 2025
Shots:
- Teva Pharmaceuticals and Prestige Biopharma have signed a license and supply agreement to commercialize Tuznue (trastuzumab), a Herceptin biosimilar, in most European markets
- As per the deal, Teva will market and distribute Tuznue in most European markets, while Prestige Biopharma will handle production and supply from its EU-GMP-certified facilities
- Tuznue, biosimilar of Herceptin, with comparable efficacy and safety, approved for treating HER2-positive metastatic and early breast cancer, as well as metastatic gastric cancer
Company: Polpharma Biologics
Product: Ranivisio PFS
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: Oct 21, 2025
Shots:
- Polpharma Biologics has launched Ranivisio pre-filled syringe (PFS), a biosimilar version of Lucentis (ranibizumab) in France
- Bioeq AG, a joint venture of Polpharma & Formycon, develops & licenses Ranivisio PFS, with Teva holding exclusive commercialization rights in France. The drug substance is manufactured by Rezon Bio (Polpharma Biologics) in Poland
- Ranibizumab is a recombinant humanized IgG1 mAb fragment that targets & inhibits VEGF-A for the treatment of wet age-related macular degeneration, retinal vein occlusion, & diabetic macular edema
Company: Biocon Biologics
Product: Yesintek & Yesintek IV
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: Oct 23, 2025
Shots:
- Biocon Biologics has received Health Canada’s NOC for Yesintek & Yesintek IV, biosimilars to Stelara, with approval on Oct 17 and commercial availability expected in mid-October
- Approval was supported by data showing YESINTEK is highly similar to Stelara with no meaningful differences in efficacy, safety, or immunogenicity. It will be offered via the My Biocon Biologics support program in SC forms (45 mg/0.5 mL; 90 mg/mL) and as an IV solution (130 mg/26 mL)
- Yesintek (ustekinumab) and Yesintek IV are fully human IgG1κ mAb targeting the p40 subunit of IL-12 and IL-23, key cytokines in immune-mediated diseases
Company: Samsung Bioepis and Biogen
Product: Byooviz and Opuviz
Active Ingredient: Ranibizumab and Aflibercept
Reference Product: Lucentis and Eylea
Reference Product Company: Genentech and Bayer
Disease: All Approved Indication
Date: Oct 29, 2025
Shots:
- Samsung Bioepis has entered an asset purchase agreement with Biogen to acquire its ophthalmology assets, Byooviz & Opuviz, biosimilar versions of Lucentis (ranibizumab) & Eylea (aflibercept), in the EU
- Samsung Bioepis will assume full responsibility for the commercialization of Byooviz following the transfer of rights from Biogen, effective January 2026
- Byooviz was approved by the EC in 2021 & was launched in the EU in 2023, while Opuviz received EC & MHRA’s approval in 2024 & 2025, respectively, for multiple retinal diseases, & will be launched after the expiry or revocation of Eylea’s related EU patents
Company: Fresenius Kabi
Product: Conexxence and Bomyntra
Active Ingredient: Denosumab
Reference Product: Prolia & Xgeva
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Oct 29, 2025
Shots:
- The US FDA has granted interchangeable designation to Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab), respectively, for the treatment of bone & skeletal disorders
- Conexxence treats adults at high fracture risk, incl. pts with osteoporosis, pts on long-term glucocorticoid therapy or certain cancer treatments affecting bone density
- Bomyntra 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: Celltrion
Product: Stoboclo & Osenvelt
Active Ingredient: Denosumab
Reference Product: Prolia & Xgeva
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Oct 29, 2025
Shots:
- The US FDA has granted interchangeable designation to Stoboclo & Osenvelt, biosimilar versions of Prolia & Xgeva (denosumab), respectively, for all approved indications of the reference product
- Designation was based on extensive data, incl. analytical data demonstrating similarity of Stoboclo & Osenvelt with reference product & P-III trial results in postmenopausal women with osteoporosis, which showed comparable efficacy, PK/PD, safety, & immunogenicity
- Stoboclo & Osenvelt were launched in the US in Jul 2025 & are available as 60mg/mL & 120mg/1.7 mL (70mg/mL) injections, respectively
Company: GlycoNex
Product: SPD8
Active Ingredient: Denosumab
Reference Product: Prolia & Xgeva
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Oct 29, 2025
Shots:
- GlycoNex has dosed the last patient with SPD8, a biosimilar version of Prolia/Xgeva (denosumab), in its P-III trial for the treatment of primary osteoporosis from solid tumors
- Trial will assess the PK, efficacy, & safety of SPD8 vs reference denosumab in postmenopausal women with osteoporosis; top-line results are expected in Q2’26 & data will support global registration
- Additionally, SPD8 has been out-licensed in select regions, with discussions ongoing with several companies for additional territory-specific development & commercialization partnerships
Related Post: Key Biosimilars Events of September 2025
