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June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC), and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology, ophthalmology, oncology, osteoporosis, and reproductive medicine.
Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.
Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.
Celltrion Seeks…
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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 …
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Teva has launched Ahzantive, a biosimilar version of Eylea, in EU, with pre-filled syringe launches beginning in May 2026 in France, Germany, Spain, & the Netherlands, and additional market launches planned later in 2026
Ahzantive received EC approval in 2025 for the treatment of wet age-related macular degeneration, diabetic macular edema, visual impairment due…
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Samsung Bioepis to directly commercialize Opuviz 40 mg/mL solution for injection in a vial, a biosimilar version of Eylea (aflibercept), across the EU
Opuviz is indicated to treat wet age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), diabetic macular oedema (DME), and…
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Formycon and licensing partner Klinge Biopharma have reported the EU launch of FYB203, a biosimilar version of Eylea 2mg (aflibercept)
FYB203 is now available in the EU as a PFS under the brand names Ahzantive and Baiama. The launch began on May 15, 2026, in key markets including Germany, France, and Italy, with further expansion across Central and Eastern Europe planned…
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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…
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Formycon has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of FYB203, a biosimilar version of Eylea 2 mg (aflibercept 0.05 ml of 40 mg/mL solution), in the EU
Under the agreement, both products may launch in the EU and other regions, including LATAM and Asia-Pacific, from May 2026. Earlier, in October 2025, Formycon secured…
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Sandoz has reported Enzeevu (Aflibercept), a biosimilar version of Eylea, is now available in Canada
Enzeevu is a single-use, PFS intravitreal injection delivering 2 mg aflibercept (2 mg/0.05 mL). It closely resembles the reference product
Enzeevu is approved for all its indications, including neovascular (wet) age-related macular degeneration (AMD), macular edema due to CRVO or BRVO, diabetic macular edema (DME), and myopic…
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Samsung Bioepis has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of SB15, a biosimilar version of Eylea 2 mg (aflibercept 40 mg/mL solution), in markets excluding the US and Canada
The agreement allows Samsung Bioepis to launch SB15 in the UK from Jan 2026, across the EU from Apr 2026,…
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Alvotech has signed a settlement and license agreement with Regeneron and Bayer for Eylea 2 mg (aflibercept) biosimilar. With prior US rights effective Q4’26, Alvotech now holds worldwide manufacturing and supply rights for its commercial partners
The settlement enables Alvotech and partners to launch the biosimilar from Jan 1, 2026, in the UK and Canada, May 1, 2026,…

