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NEWS

Mabwell Reports ASEAN Partnerships for Its Aflibercept Biosimilar (Biosimilar, Eylea) 

 Shots:  Mabwell has signed licensing and commercialization agreements with local partners in the Philippines, Vietnam, and Malaysia for its aflibercept biosimilar, a biosimilar version of Eylea  As per the deal, Mabwell and its partners jointly advance the product’s registration and commercialization in these markets  Aflibercept is a VEGF inhibitor approved for the treatment of Neovascular (wet) age-related macular…
August 11, 2026

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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

Outlook Therapeutics Reports the US FDA Approval of Lytenava for Wet AMD 

Shots:  The US FDA has approved Outlook’s Lytenava (Bevacizumab-vikg) for wet AMD    Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized IgG1 MAb targeting VEGF  Additionally, the approval is expected to provide LYTENAVA with 12 years of Reference Product Exclusivity under the BPCIA  Ref:  Outlook Therapeutics |  Image: Outlook Therapeutics |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications.…
July 24, 2026

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Celltrion
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Celltrion Receives ANVISA Approval for Eydenzelt (Biosimilar, Eylea) 

Shots:  The ANVISA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept)  Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor  Eydenzelt is indicated for adults with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (CRVO/BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (CNV)  Ref: Gov.br |   Image: Celltrion   | Press Release Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea  …
June 15, 2026

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NEWS

Lupin Receives US FDA Approval for Ranluspec (Biosimilar, Lucentis) 

Shots:  The US FDA has approved Ranluspec (ranibizumab-hkdz), a biosimilar version of Lucentis (ranibizumab)  Ranluspec is an interchangeable ranibizumab biosimilar approved in the US, available in both vials and PFS at 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL) strengths, matching Lucentis  It is a recombinant humanized IgG1 mAb fragment that inhibits VEGF-A and is indicated for wet age-related macular degeneration,…
June 5, 2026

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NEWS

Zydus Partners with Bioeq for US Commercialization of Nufymco (Biosimilar, Lucentis)

Shots: Zydus Lifesciences has entered into a strategic licensing, supply & commercialization agreement with Bioeq for Nufymco (ranibizumab), an interchangeable biosimilar to Lucentis, for the US market, marking an expansion of Zydus’ US biosimilar portfolio Under the agreement, Bioeq will handle development, manufacturing, registration & supply of the finished product while Zydus will lead US…
December 25, 2025

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Teva and Alvotech
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Alvotech and Teva Enter into an Agreement with Regeneron to Launch AVT06 (Biosimilar, Eylea) Across US  

Shots:  Alvotech and Teva reached a settlement and license agreement with Regeneron, allowing the US launch of AVT06, a biosimilar version of Eylea (aflibercept) in Q4’26 or earlier under certain conditions   AVT06 is an aflibercept (Eylea) biosimilar that inhibits VEGF and has been approved as Mynzepli in the UK and EEA and as Aflibercept BS in Japan   On…
December 19, 2025

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NEWS

Biocon Biologics Inks Settlement and Licensing Deal with Regeneron and Bayer for Worldwide Commercialization of Yesafili (Biosimilar, Eylea) 

Shots:  Biocon Biologics has signed a settlement and license agreement with Regeneron and Bayer for Yesafili (Biosimilar, Eylea) in the EU and globally, following a prior US and Canada settlement  Biocon Biologics, Regeneron, and Bayer settled all pending litigation, allowing Yesafili’s UK launch in Jan’26 and other countries by Mar’26 or earlier. YESAFILI launched in Canada in 2024, and US market entry secured in April…
December 13, 2025

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NEWS

Outlook Therapeutics Reports the US FDA’s BLA Acceptance of ONS-5010 to Treat Wet Age-Related Macular Degeneration (wAMD)

Shots: The US FDA has accepted the resubmitted BLA of ONS-5010 (bevacizumab-vikg) for the treatment of wAMD, considering a Class 1 review & granting a PDUFA goal date Dec 31, 2025; if approved, it will be branded Lytenava ONS-5010 (intravitreal) is an ophthalmic bevacizumab formulation that binds all VEGF isoforms to block VEGF interaction with…
November 14, 2025

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