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The FDA approved Ranluspec, an interchangeable biosimilar referencing Lucentis, as a treatment for vision-threatening retinal diseases, according to a press release from Lupin.
The approval covers Ranluspec (ranibizumab-hkdz) as a vial and a prefilled syringe at two strengths: 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL). The recombinant humanized IgG1 monoclonal antibody fragment inhibits VEGF and is indicated for wet age-related macular degeneration, macular edema following retinal vein