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Samsung Bioepis
NEWS

Samsung Bioepis Began Direct Commercialization of Byooviz (Biosimilar, Lucentis) Across Europe

Shots: Samsung Bioepis has reported the direct commercialization of Byooviz, a biosimilar version of Lucentis (ranibizumab) across Europe, with market availability expected in Q2’26 Byooviz (0.5 mg/0.05 ml) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due…
January 2, 2026

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NEWS

Zydus Partners with Bioeq for US Commercialization of Nufymco (Biosimilar, Lucentis)

Shots: Zydus Lifesciences has entered into a strategic licensing, supply & commercialization agreement with Bioeq for Nufymco (ranibizumab), an interchangeable biosimilar to Lucentis, for the US market, marking an expansion of Zydus’ US biosimilar portfolio Under the agreement, Bioeq will handle development, manufacturing, registration & supply of the finished product while Zydus will lead US…
December 25, 2025

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NEWS

Formycon Receives the US FDA Approval for Nufymco (Biosimilars, Lucentis)

Shots:  The US FDA has approved Nufymco (ranibizumab-leyk), an interchangeable biosimilar of Lucentis, with Zydus serving as its commercialization partner in the US  Nufymco is an interchangeable Lucentis biosimilar developed by Formycon, approved for the treatment of wet AMD, diabetic macular edema, diabetic retinopathy, retinal vein occlusion-related macular edema, and myopic choroidal neovascularization  Zydus secured exclusive US and Canada rights to Formycon’s Keytruda…
December 23, 2025

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Teva and Alvotech
NEWS

Alvotech and Teva Enter into an Agreement with Regeneron to Launch AVT06 (Biosimilar, Eylea) Across US  

Shots:  Alvotech and Teva reached a settlement and license agreement with Regeneron, allowing the US launch of AVT06, a biosimilar version of Eylea (aflibercept) in Q4’26 or earlier under certain conditions   AVT06 is an aflibercept (Eylea) biosimilar that inhibits VEGF and has been approved as Mynzepli in the UK and EEA and as Aflibercept BS in Japan   On…
December 19, 2025

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NEWS

Lupin Receive the CHMP Positive Opinion for Ranluspec (Biosimilar, Lucentis) 

Shots:  The CHMP has recommended marketing authorization for Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab)  Opinion was supported by analytical similarity data and a global P-III trial (n=600 pts) in neovascular AMD across the US, EU, Russia, and India  Under the agreement, Lupin’s biosimilar ranibizumab will be marketed by Sandoz across the EU (excluding Germany),…
December 17, 2025

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NEWS

Biocon Biologics Inks Settlement and Licensing Deal with Regeneron and Bayer for Worldwide Commercialization of Yesafili (Biosimilar, Eylea) 

Shots:  Biocon Biologics has signed a settlement and license agreement with Regeneron and Bayer for Yesafili (Biosimilar, Eylea) in the EU and globally, following a prior US and Canada settlement  Biocon Biologics, Regeneron, and Bayer settled all pending litigation, allowing Yesafili’s UK launch in Jan’26 and other countries by Mar’26 or earlier. YESAFILI launched in Canada in 2024, and US market entry secured in April…
December 13, 2025

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NEWS

EyeYon Medical Receives the US FDA’s IDE Approval to Initiate US Study of EndoArt for Chronic Corneal Edema

Shots: EyeYon Medical secured FDA IDE approval to initiate the first US clinical study of EndoArt, a synthetic endothelial layer and an FDA-designated Breakthrough Device for chronic corneal edema The study will involve 10+ leading US cornea surgeons, evaluating EndoArt as a novel alternative for patients unsuitable for human tissue implantation EndoArt has already seen…
December 9, 2025

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INSIGHTS+

Key Biosimilars Events of November 2025  

Shots:        Regulatory momentum accelerates globally, with major approvals across the US, EU, UK, and Canada for biosimilars targeting high-value biologics such as Simponi, Stelara, Perjeta, Prolia/Xgeva, Remicade, Xolair, Eylea, Lucentis, and Lantus SoloStar, strengthening patient access in immunology, oncology, ophthalmology, diabetes, and allergy/asthma  Sandoz, Alvotech, Celltrion, Henlius/Organon, Teva, and others expand portfolios and market reach, including multiple EC and…
December 2, 2025

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