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Samsung Bioepis
NEWS

Samsung Bioepis Launches Opuviz 40 mg/mL PFS (Biosimilar, Eylea) in the EU 

 Shots:  Samsung Bioepis has reported the commercial launch of Opuviz 40 mg/mL solution (PFS), a biosimilar version of Eylea (aflibercept) across the EU  Opuviz (aflibercept) is a VEGF inhibitor that blocks abnormal blood vessel growth and leakage in the eye. Samsung Bioepis launched the 40 mg/mL vial in May’26. The PFS formulation received a positive CHMP opinion in Nov’25 for the same indications  Opuviz 40…
August 10, 2026

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NEWS

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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Celltrion
NEWS

Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives the US FDA’s Approval to Treat Multiple Retinal Diseases

Shots: The US FDA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept), to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), & diabetic retinopathy Approval was supported by extensive analytical, non-clinical, & clinical data, incl. a P-III trial in DME pts (n=348) comparing Eydenzelt vs Eylea over…
October 10, 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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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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Regeneron New
NEWS

The US FDA Accepts sBLA Priority Review for Regeneron’s EYLEA HD in Macular Edema Following RVO and Monthly Dosing In Approved Indications

Shots: Regeneron reported the US FDA acceptance for its priority review of the sBLA by using priority review voucher for EYLEA HD (aflibercept 8 mg) to treat macular edema from retinal vein occlusion (RVO) and to expand dosing to include monthly administration in all approved indications. The US FDA’s expected action date is Aug 19,…
April 18, 2025

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