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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 Q4’25Formycon & 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
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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 & ArgentinaAs per the deal, SteinCares will be responsible for the biosimilar’s regulatory filings, registration, & commercialization in LATAM licensed states, while Lupin will oversee its manufacturingRanibizumab is a recombinant humanized…
May 26, 2025

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xbrane
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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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