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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,…

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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…

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AstraZeneca & Alteogen

AstraZeneca and Alteogen Enter an Exclusive License Deal for ALT-B4 to Develop & Market Subcutaneous Formulations of Multiple Oncology Drugs

Shots: Alteogen has granted AstraZeneca global rights of ALT-B4 to develop & commercialize SC formulations of multiple oncology assets, while Alteogen will be responsible for clinical & commercial supply of ALT-B4 As per the deal, Alteogen will receive an upfront, along with development, regulatory, & sales milestones, plus royalties on sale of commercialized products…

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Insights+ Key Biosimilars Events of February 2023

Insights+ Key Biosimilars Events of February 2023

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of February, Alvotech entered into a commercialization agreement…

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Insights+ Key Biosimilars Events of March 2021

Insights+ Key Biosimilars Events of March 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of March, Samsung Bioepis Initiated P-I Study of SB17…

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