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
- Alvotech & Advanz Pharma Secure the CHMP’s Positive Opinion for AVT06. Our team at PharmaShots has summarized 12 key events of the biosimilar space of June 2025
Company: Sandoz
Product: Wyost and Jubbonti
Active Ingredient: Denosumab
Reference Product: Xgeva and Prolia
Reference Product Company: Bayer
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Jun 02, 2025
Shots:
- Sandoz has launched Wyost & Jubbonti, interchangeable biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) in the US
- Jubbonti (60mg/1mL) 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
- Wyost (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: Alvotech & Dr. Reddy’s
Product: Pembrolizumab
Active Ingredient: Pembrolizumab
Reference Product: Keytruda
Reference Product Company: Merck
Disease: All Approved Indications
Date: Jun 05, 2025
Shots:
- Alvotech has entered into a collaboration & license agreement with Dr. Reddy’s to co-develop, manufacture & commercialize a biosimilar of Merck’s Keytruda (pembrolizumab) globally
- As per the deal, Alvotech & Dr. Reddy’s will jointly develop & manufacture this biosimilar, sharing costs & responsibilities, with each retaining the right to commercialize it globally, subject to certain exceptions
- Pembrolizumab is a highly selective humanized mAb, which binds with PD-1 receptor to prevent its interaction with PD-L1 & PD-L2 ligands
Company: Formycon
Product: Ranivisio
Active Ingredient: Ranibizumab
Reference Product: Lucentis
Reference Product Company: Roche & Novartis
Disease: Neovascular Age-Related Macular Degeneration, Macular Edema Following RVO, Diabetic Macular Edema, Diabetic Retinopathy, Myopic Choroidal Neovascularization
Date: Jun 05, 2025
Shots:
- Brazil’s ANVISA has approved marketing authorization for Formycon’s Ranivisio (ranibizumab), a biosimilar to Lucentis; launch is anticipated in Q4’25
- Formycon & Biomm have partnered to commercialize Ranivisio in Latin America, with approvals already granted in Peru, El Salvador, Honduras, and the Dominican Republic. Additional launches across Central and South America are planned in early 2027
- Ranivisio (FYB201), developed by Bioeq AG, a joint venture of Formycon & Polpharma Biologics, treats conditions like wet AMD and other retinopathies. It is available in 21 countries across Europe, North America, and the MENA region
Company: Samsung Bioepis & NIPRO
Product: SB17
Active Ingredient: Ustekinumab
Reference Product: Stelara
Reference Product Company: Johnson & Johnson
Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis
Date: Jun 08, 2025
Shots:
- Samsung Bioepis & NIPRO have entered into a license, development & commercialization agreement for various biosimilar candidates, incl. SB17, a biosimilar version of Stelara (ustekinumab) in Japan
- As per the deal, NIPRO will be responsible for commercialization of the biosimilar candidates in Japan, with Samsung Bioepis handling development, manufacturing & supply activities
- Ustekinumab is a fully human anti-IL-12/IL-23 mAb indicated for the treatment of autoimmune diseases incl. plaque psoriasis, psoriatic arthritis & Crohn’s disease
Company: Celltrion
Product: Steqeyma
Active Ingredient: Ustekinumab
Reference Product: Stelara
Reference Product Company: Johnson & Johnson
Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis
Date: Jun 15, 2025
Shots:
- The US FDA has approved Steqeyma (45mg/0.5mL, SC, single-dose vial), a biosimilar version of Stelara (ustekinumab) for the treatment of pts (6-17yrs.; ≤60kg) with plaque PsO or PsA
- Approval was supported by extensive clinical data, incl. P-III trial of Steqeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change in the PASI for skin symptoms, showing similar safety & efficacy b/w both the drugs
- Steqeyma is available as SC injection (45mg/0.5mL or 90mg/1mL) & IV infusion (130mg/26mL), with approved interchangeability for all Stelara indications following exclusivity expiration on April 30, 2025
Company: Bio-Thera Solutions
Product: Usymro
Active Ingredient: Ustekinumab
Reference Product: Stelara
Reference Product Company: Johnson & Johnson
Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis
Date: Jun 20, 2025
Shots:
- The CHMP has recommended Usymro (BAT2206), a biosimilar of Stelara (ustekinumab) for all indications of the reference product
- Opinion was based on comprehensive analytical, non-clinical, & clinical data incl. extensive analytical characterization, P-I trial in healthy subjects & P-III trial in mod. to sev. plaque PsO pts, showing similar efficacy, safety, PK & immunogenicity of Usymro vs US & EU Stelara
- In Oct 2024, Bio-Thera & Gedeon Richter entered a licensing & commercialization deal under which Bio-Thera will develop & manufacture Usymro, while Gedeon will commercialize it post-approval & MA Holder transfer in the EU, UK, & Switzerland
Company: Sandoz
Product: Wyost and Jubbonti
Active Ingredient: Denosumab
Reference Product: Prolia and Xgeva
Reference Product Company: Bayer
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Jun 22, 2025
Shots:
- The EC has granted approval to the company’s Wyost and Jubbonti, biosimilar of Xgeva and Prolia (denosumab), across the EU for treating same indications as that of Xgeva and Prolia incl. cancer-related bone disease & osteoporosis, respectively. Their launch is anticipated from Nov 2025 onwards
- The EC’s approval was supported by the clinical evaluations verifying the similarity in safety, effectiveness and quality of biosimilars with their reference drugs
- Wyost and Jubbonti consist of denosumab as an active ingredient and a human mAb IgG2 that attaches with RANKL to prevent RANK activation on osteoclasts and their precursors, inhibiting osteoclast formation, function & survival. This reduces bone resorption in both cortical as well as trabecular bone
Company: Alvotech & Advanz Pharma
Product: AVT06
Active Ingredient: Aflibercept
Reference Product: Eylea
Reference Product Company: Bayer & Regeneron
Disease: Neovascular Age-Related Macular Degeneration (nAMD) & Other Retinal Diseases
Date: Jun 22, 2025
Shots:
- The CHMP has recommended AVT06, a biosimilar version of Eylea (aflibercept 2 mg), across all 30 EEA states
- AVT06 is a recombinant fusion protein that inhibits VEGF to reduce neovascularization and vascular permeability. The CHMP recommends MAA for wet AMD, visual impairment from macular oedema due to RVO (branch or central), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV)
- Alvotech develops and supplies biosimilars, while Advanz Pharma handles registration and has exclusive commercialization rights in most EU countries. Advanz also holds distribution rights for AVT29, Alvotech’s proposed biosimilar to Eylea HD (aflibercept 8 mg), in the same region
Company: Valorum Biologics and Formycon
Product: FYB203/Ahzantive
Active Ingredient: Aflibercept-mrbb
Reference Product: Eylea
Reference Product Company: Bayer & Regeneron
Disease: Neovascular Age-Related Macular Degeneration (nAMD) & Other Retinal Diseases
Date: Jun 25, 2025
Shots:
- Formycon has reported that Klinge Biopharma, holder of global rights to FYB203/Ahzantive (aflibercept-mrbb), has signed an exclusive licensing deal with Valorum Biologics for commercialization across the US and Canada
- As per the deal, Klinge will receive upfront, milestone, and royalty payments on net sales. Formycon will receive a mid-single—to low-double-digit percentage of all payments made to Klinge. It will manage the FYB203 supply chain for Klinge and receive service fees plus volume-based profit.
- ATHOS KG, a key Formycon shareholder, is leading Valorum’s Series A funding, showing confidence in Valorum’s strategy and FYB203’s potential. Canadian approval of FYB203 is expected by YE’25
Company: Bio-Thera Solutions and SteinCares
Product: Dupilumab
Active Ingredient: Dupilumab
Reference Product: Dupixent
Reference Product Company: Sanofi & Regeneron
Disease: Mod-to-Sev Eczema, Eosinophilic, Chronic Rhinosinusitis with Nasal Polyps, Eosinophilic Esophagitis, Prurigo Nodularis, Chronic Spontaneous Urticaria, Bullous Pemphigoid
Date: Jun 25, 2025
Shots:
- Bio-Thera Solutions & SteinCares signed an agreement to commercialize a proposed dupilumab biosimilar for inflammatory diseases in Latin America
- As per the deal, Bio-Thera will handle product development and supply, while SteinCares manages registration and commercialization in Latin America
- Dupilumab (SC) is a fully human mAb that blocks IL-4 and IL-13 signalling pathways and is not an immunosuppressant
Company: Kashiv BioSciences and Amneal Pharmaceuticals
Product: ADL-018
Active Ingredient: Omalizumab
Reference Product: Xolair
Reference Product Company: Roche & Novartis
Disease: Chronic Idiopathic Urticaria/Chronic Spontaneous Urticaria
Date: Jun 25, 2025
Shots:
- Kashiv BioSciences has reported topline results of ADL-018, its proposed biosimilar to Xolair (omalizumab) for Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) unresponsive to H1 antihistamines. The BLA and MAA filings for the product are expected with the FDA and EMA, respectively, in Q4’25
- The study met its 1EPs & 2EPs, demonstrating therapeutic equivalence and comparable safety & efficacy between ADL-018 and XOLAIR. Involving 600 pts, 400 received a confirmatory 300 mg dose Q4W for 24 wks. The primary efficacy measure was the change in weekly ISS7 at Wk. 12
- ADL-018 is a humanized mAb designed to block IgE binding to FcεR on mast cells and basophils, targeting CSU in patients 12+ with hives unresponsive to H1 antagonists
Company: Biocon Biologics
Product: Yesafili
Active Ingredient: Aflibercept
Reference Product: Eylea
Reference Product Company: Bayer & Regeneron
Disease: Neovascular Age-Related Macular Degeneration (nAMD) & Other Retinal Diseases
Date: Jun 27, 2025
Shots:
- Health Canada has granted NOC for Yesafili (vial & PFS presentations, 2 mg/0.05 mL), a biosimilar to Eylea (aflibercept), anticipated launch on Jul 04, 2025
- Approval was supported by the P-III (INSIGHT) study in Diabetic Macular Edema(DME), which showed no clinically meaningful differences from EYLEA in PK, safety, efficacy, or immunogenicity.
- YESAFILI is a VEGF inhibitor approved for the treatment of Neovascular (wet) age-related macular degeneration (AMD), Visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO), Visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO), DME, and Myopic choroidal neovascularization (myopic CNV)
Note: The following biosimilar received the CHMP’s Positive Opinion. However, as of June 30, 2025, no PR was available:
- Afiveg (Biosimilar, Aflibercept)
- Eiyzey (Biosimilar, Aflibercept)
- Vgenfli (Biosimilar, Aflibercept)
- Vivlipeg (Biosimilar, Pegfilgrastim)
Related Post: Key Biosimilars Events of May 2025
