Lupin gets US FDA approval for Ranluspec biosimilar

Lupin Limited has received approval from the U.S. Food and Drug Administration (FDA) for its ranibizumab injection, RanluspecTM (ranibizumab-hkdz). This marks Lupin's second U.S. biosimilar and is noted as the only interchangeable biosimilar ranibizumab approved in the U.S. available in both vials and pre-filled syringes. RanluspecTM is indicated for various eye conditions, including wet age-related macular degeneration and diabetic macular edema. The company views this approval as a significant step in expanding its biosimilars portfolio and enhancing patient access to affordable, high-quality vision therapies.