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NEWS

Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s Positive Opinion for Retinal Diseases

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…
July 30, 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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Lupin & Steincares
NEWS

Lupin Collaborates with SteinCares to Commercialize Ranibizumab Biosimilar in Latin America

Shots: Lupin & SteinCares have entered into a license & supply agreement to commercialize Lupin’s ranibizumab biosimilar in Latin America excl. Mexico & Argentina As per the deal, SteinCares will be responsible for the biosimilar’s regulatory filings, registration, & commercialization in LATAM licensed states, while Lupin will oversee its manufacturing Ranibizumab is a recombinant humanized…
May 26, 2025

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xbrane
NEWS

Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate 

Shots:  Xbrane Biopharma has resubmitted the BLA for its biosimilar product, referencing Genentech’s Lucentis (ranibizumab), to the US FDA post issuance of CRL in Apr 2024  The CRL stated requirement for additional information on the reference standard and follow-up actions from manufacturing site inspections. Xbrane has addressed the issues, qualifying new reference standard & completing…
December 31, 2024

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