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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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Samsung Bioepis, in partnership with Harrow, has relaunched Byooviz, a biosimilar to Lucentis (ranibizumab), in the US
Byooviz was initially commercialized by Biogen beginning in Jun 2022, before Biogen returned the US commercial rights to Samsung Bioepis at the end of 2025
Approved by the FDA in 2021 as the first ophthalmology biosimilar, Byooviz…
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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,…
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The EC has approved Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab)
Ranibizumab is a recombinant humanized IgG1 antibody fragment that inhibits VEGF-A and is used to treat wet AMD, macular edema due to retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization
Sandoz and Lupin Limited partnered in August 2025 to develop and…
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The Ghana FDA has approved BioUcenta, a biosimilar version of Lucentis (ranibizumab) for diabetic macular edema, age-related macular degeneration, and diabetic retinopathy
The Ghana FDA approval followed a rigorous, science-based review referencing comprehensive data previously evaluated and accepted by the EMA
BioUcenta is exclusively licensed to Bio Usawa for Sub-Saharan Africa by Bioeq AG
Ref: Bio Usawa | Image: Bio Usawa | Press Release
Related News: CuraTeQ Biologics Reports Positive P-III study…
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Samsung Bioepis has reported the direct commercialization of Byooviz, a biosimilar version of Lucentis (ranibizumab) across Europe, with market availability expected in Q2’26
Byooviz (0.5 mg/0.05 ml) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due…
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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…
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The CHMP has recommended marketing authorization for Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab)
Opinion was supported by analytical similarity data and a global P-III trial (n=600 pts) in neovascular AMD across the US, EU, Russia, and India
Under the agreement, Lupin’s biosimilar ranibizumab will be marketed by Sandoz across the EU (excluding Germany),…
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The CHMP has recommended Samsung Bioepis’ Byooviz (0.5 mg/0.05 ml PFS), a biosimilar version of Lucentis (ranibizumab). The PFS presentation is expected to launch in Q2’26
Byooviz is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and…
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Sandoz commercializes Epruvy (Biosimilar, Lucentis) across Germany in PFS and vial forms, following an agreement with Formycon and Bioeq
Epruvy (ranibizumab)was approved by the EMA in Sep'24 to treat severe visual impairments like nAMD and other retinopathies and is marketed by Sandoz in Germany under a Bioeq license
Epruvy is available in vials and pre-filled syringes, offering a convenient treatment option in Germany
Ref: Formycon | Image: Formycon | Press Release
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