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NEWS

Apotex Receives Health Canada Approval for Aflivu (Biosimilar, Eylea)   

Shots:  Apotex has reported Health Canada's approval of Aflivu (aflibercept), a biosimilar to Eylea in PFS and vials  Aflivu is indicated for wet age-related macular degeneration, macular edema from retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization  Aflivu expands Apotex's biosimilar portfolio, which already includes Grastofil (filgrastim), Lapelga (pegfilgrastim), and Bambevi (bevacizumab)  Ref: PRNewsWire | Image:…
July 2, 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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Biocon Biologics
NEWS

Biocon Biologics and Regeneron Settle over Yesafili’s (Biosimilar, Eylea) US Launch

Shots: Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26 Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK,…
April 16, 2025

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Viewpoints_Uwe Gudat
VIEWPOINTS

Biocon Biologics at AAO 2024: Uwe Gudat in an Invigorating Discussion with PharmaShots

Shots: At the American Academy of Ophthalmology (AAO 2024), Biocon Biologics announced promising results from the extension study of its proposed biosimilar to aflibercept, MYL-1701P The study demonstrated comparable safety, efficacy, and immunogenicity between patients continuing MYL-1701P and those who switched from aflibercept to MYL-1701P Biocon Biologics' Chief Medical Officer, Uwe Gudat, discusses the groundbreaking…
March 17, 2025

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NEWS

Teva Partners with Klinge Biopharma & Formycon to Commercialize FYB203 (Biosimilar: Aflibercept) in EU & Israel

Shots: Teva Pharmaceuticals International secured semi-exclusive marketing rights for FYB203, a biosimilar of Eylea (aflibercept), in Europe (excl. Italy) & Israel via a deal with Klinge & Formycon, boosting Teva’s biosimilar portfolio The deal combines Teva’s commercial expertise & distribution network with Formycon’s biosimilar development capabilities, following their successful collaboration on marketing FYB201, a…
January 14, 2025

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Celltrion
NEWS

Celltrion Secures the CHMP’s Positive Opinion for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva) and Avtozma (Biosimilar, RoActemra) 

Shots:  The P-III trial of Eydenzelt vs Eylea (aflibercept) in diabetic macular edema (DME) patients achieved its 1EP of BCVA improvement at wk.8, demonstrating equivalent efficacy, safety & immunogenicity  The P-III study of Stoboclo & Osenvelt vs Prolia & Xgeva (denosumab) in patients (n=479) achieved its 1EP, showing equivalent efficacy in lumbar spine bone mineral…
December 16, 2024

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Celltrion
NEWS

Celltrion Secures the CHMP’s Positive Opinion for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva) and Avtozma (Biosimilar, RoActemra)

Shots:  The P-III trial of Eydenzelt vs Eylea (aflibercept) in diabetic macular edema (DME) patients achieved its 1EP of BCVA improvement at wk.8, demonstrating equivalent efficacy, safety & immunogenicity  The P-III study of Stoboclo & Osenvelt vs Prolia & Xgeva (denosumab) in patients (n=479) achieved its 1EP, showing equivalent efficacy in lumbar spine bone mineral…
December 16, 2024

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Formycon and Fresenius Kabi
NEWS

Fresenius Kabi and Formycon Report the CHMP’s Positive Opinion of Ahzantive/Baiama/FYB203 (Biosimilar, Eylea) 

Shots:  The CHMP has recommended FYB203 under the brand names, Ahzantive/Baiama, biosimilar version of Eylea (aflibercept), with the decision anticipated in 2nd half of Jan’25   The approval, if granted, will be valid across the whole EU, as well as in Iceland, Liechtenstein & Norway. It is already approved across the US in Jun 2024  FYB203…
November 18, 2024

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