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INSIGHTS+

Key Biosimilars Events of May 2026 

Shots:  May 2026 saw strong biosimilar momentum with key approvals including Bevqolva (Health Canada), Langlara and Immgolis/Immgolis Intri (US FDA), Bysumlog and Dazparda (EC), and Eyzanfy (MFDS), expanding competition across oncology, diabetes, immunology, and ophthalmology.  Strategic progress continued with Henlius’ FDA IND clearance for HLX05-N, alongside partnerships between IQVIA–Kexing Biopharm and Polpharma–Tuteur, supporting global development and commercialization efforts.  Commercialization accelerated through the EU launches of FYB203 and Opuviz, as well as Samsung Bioepis’ ustekinumab biosimilar launch in Japan,…
June 2, 2026

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NEWS

Alteogen Reports the MFDS Approval of Eyzanfy (Biosimilar, Eylea) 

Shots:  The Korean MFDS has approved Eyzanfy (ALT-L9), a biosimilar version of Eylea (aflibercept)  In 2025, ALT-L9 received EC approval as a brand name of Eyluxvi  Approval was based on P-III trial across 12 countries in 431 wAMD pts, demonstrating Eyluxvi’s efficacy, safety, and therapeutic equivalence comparable to Eylea  Ref: Alteogen | Image: Alteogen | Press Release Related News:- Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s…
May 15, 2026

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NEWS

Biogen and Alteogen Partner for ALT-B4 to Advance Subcutaneous Formulations of Biologics

Shots: Alteogen has granted Biogen exclusive rights to ALT-B4 (berahyaluronidase alfa) to develop & commercialize SC formulations of two biologics, with an option for Biogen to develop a third product As per the deal, Alteogen will receive $20M upfront, $10M upon initiation of second product development, along with ~$549M in development, regulatory, & sales milestones…
March 26, 2026

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NEWS

Tesaro (GSK) Licenses Alteogen’s ALT-B4 to Develop & Commercialize SC Formulation of Dostarlimab

Shots: Tesaro (GSK’s subsidiary) has entered into an exclusive license agreement to use Alteogen’s ALT-B4 for the development & commercialization of a SC formulation of dostarlimab As per the deal, Alteogen will be responsible for clinical and commercial supply of ALT-B4 to Tesaro, in exchange for $20M upfront & ~$265M in development, regulatory & sales milestones,…
January 20, 2026

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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

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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

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AstraZeneca & Alteogen
NEWS

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…
March 17, 2025

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Insights+ Key Biosimilars Events of February 2023
INSIGHTS+

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…
March 1, 2023

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Insights+ Key Biosimilars Events of March 2021
INSIGHTS+

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…
April 1, 2021

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