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Samsung Bioepis Enters Asset Purchase Deal with Biogen for Byooviz (Biosimilar, Lucentis) and Opuviz (Biosimilar, Eylea) in the EU

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…
October 29, 2025

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NEWS

Polpharma Biologics Launches Ranivisio PFS (Biosimilar, Lucentis) in the EU

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…
October 22, 2025

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Roche
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Roche Reports the European CE Mark Approval of Contivue to Treat Neovascular Age-Related Macular Degeneration

Shots: Roche has received the European CE Mark approval for Contivue, a port delivery platform containing Susvimo (Lucentis) for the treatment of neovascular age-related macular degeneration (nAMD); Susvimo (100mg/mL) is under the EMA’s review Approval was backed by P-III (Archway) trial & additional studies, a P-II (LADDER) trial, & Portal OLE long-term study, with Archway showing…
September 5, 2025

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NEWS

Lupin Collaborates with Sandoz to Commercialize Ranibizumab Biosimilar

Shots: Lupin has entered into a licensing agreement with Sandoz to market & commercialize Lupin’s ranibizumab biosimilar in multiple regions As per the deal, Sandoz will commercialize the product in the EU (excl. Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, & Malaysia, while holding exclusive rights in most markets & semi-exclusive rights in France, Australia,…
August 12, 2025

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NEWS

Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the US

Shots: Samsung Bioepis has entered into a definitive agreement to grant Harrow exclusive commercial rights of its ophthalmology biosimilar portfolio incl. Byooviz, biosimilar to Lucentis (ranibizumab), & Opuviz, biosimilar to Eylea (aflibercept) in the US Byooviz has been available in the US through Biogen since its launch in Jun 2022. In Oct 2024, Biogen notified…
July 18, 2025

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NEWS

Bio Usawa Biotechnology and Bioeq AG Partner to Expand Access to Vision-Saving Treatments Across Sub-Saharan Africa 

Shots:  Bio Usawa Biotechnology and Bioeq AG entered into an agreement to make ranibizumab biosimilar for serious retinal diseases, accessible to millions in Sub-Saharan Africa   The partnership gives Bio Usawa exclusive rights to register and market Bioeq’s ranibizumab biosimilar, BioUcenta, advancing access to essential biologics in Sub-Saharan Africa   BioUcenta, an intravitreal injection, blocks abnormal retinal…
July 1, 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
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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 & 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
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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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