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INSIGHTS+

Key Biosimilars Events of February 2026 

Shots:  Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars.  Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…
10 hours ago

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NEWS

Lupin and Sandoz Receive the EC approval for Ranluspec (Biosimilar, Lucentis) 

Shots:  The EC has approved Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab)    Ranibizumab is a recombinant humanized IgG1 antibody fragment that inhibits VEGF-A and is used to treat wet AMD, macular edema due to retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization  Sandoz and Lupin Limited partnered in August 2025 to develop and…
February 23, 2026

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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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