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NEWS

Biocon Biologics Reports the Health Canada’s NOC for Yesafili (Biosimilar, Eylea)

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…
June 27, 2025

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NEWS

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

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…
June 27, 2025

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NEWS

Bio-Thera Solutions and SteinCares Broaden Collaboration to Commercialize (Biosimilar, Dupilumab) in Latin America

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…
June 26, 2025

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NEWS

Alvotech & Advanz Pharma Secure the CHMP’s Positive Opinion for AVT06 (Biosimilar, Eylea)

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…
June 24, 2025

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Sandoz
NEWS

Sandoz Reports EC’s Approval of Wyost and Jubbonti (Biosimilars, Xgeva and Prolia) 

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…
June 23, 2025

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Bio-Thera New
NEWS

Bio-Thera Solutions Secures the CHMP’s Positive Opinion for Usymro (Biosimilar, Stelara)

Shots: The CHMP has recommended Usymro (BAT2206), a biosimilar version 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 &…
June 23, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jun 16, 2025 – Jun 20, 2025)   

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, Animal Health & DigiHealth. Check out our full report below:    Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma  Read More: J&J  Camurus Reports Topline P-IIb (POSITANO) Trial Data on CAM2029 for…
June 20, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jun 09, 2025 – Jun 13, 2025)  

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar & Animal Health. Check out our full report below:   Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN  Read More: Apellis Pharmaceuticals and Sobi  Daiichi Sankyo Reports First Patient…
June 13, 2025

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NEWS

Formycon Receives the ANVISA Approval for Ranivisio (Biosimilar, Lucentis) Across Brazil

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 through early…
June 6, 2025

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