FDA Approves Lucentis Biosimilar Nufymco

Ranibizumab-leyk (Nufymco) is approved for all Lucentis indications.

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The FDA approved Nufymco, a biosimilar of Lucentis, developed by Bioeq, a joint venture of Formycon AG and Polpharma Biologics Group.
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Nufymco is indicated for treating wet macular degeneration, diabetic macular edema, diabetic retinopathy, and other eye conditions.
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Zydus Lifesciences Limited will market Nufymco in the United States, having previously secured rights for another biosimilar.
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Dr. Stefan Glombitza, CEO of Formycon AG, highlighted the approval as a milestone in biosimilar development.
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The partnership aims to enhance access to affordable ranibizumab biosimilars for ophthalmic patients in the US.