Skip to content Skip to footer
Subscribe Now
NEWS

Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the EC’s Approval for Retinal Diseases

Shots: The EC has approved Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation Approval was based on P-III trials conducted across the EU, South Korea, & Japan,…
September 17, 2025

Read more

NEWS

Formycon and Klinge Biopharma sign a semi-exclusive licensing deal with Horus Pharma to commercialize the FYB203/Baiama (Biosimilar, Eylea)  

Shots:  Formycon and Klinge Biopharma have signed a semi-exclusive licensing deal with Horus Pharma to commercialize the FYB203/Baiama (Biosimilar, Eylea) in selected EC, following a similar agreement with Teva in Jan for covering major parts of the EU & Israel  Klinge will receive upfront, milestone payments, and royalties on net sales, with Formycon earning a…
September 17, 2025

Read more

NEWS

Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s Positive Opinion for Retinal Diseases

Shots: The CHMP has recommended Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation Opinion was based on extensive analytical, non-clinical, & clinical data incl. a P-III trial…
July 30, 2025

Read more

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

Read more

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

Read more

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

Read more

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

Read more

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

Read more

Load more