← Back to feed Ranluspec cleared as interchangeable Lucentis biosimilar
Sponsor Lupin Limited
Drug Ranluspec · ranibizumab-hkdz
Indication Neovascular (wet) age-related macular degeneration; macular oedema following retinal vein occlusion; diabetic macular oedema; diabetic retinopathy; myopic choroidal neovascularization — as an interchangeable biosimilar to Lucentis More on Lupin Limited ↗ Google News FDA approved Lupin's Ranluspec (ranibizumab-hkdz) as an interchangeable biosimilar to Lucentis for the treatment of neovascular (wet) age-related macular degeneration, macular oedema, and other approved Lucentis indications.
Read original at drugs.com ↗ Background Drug-class context · Wikipedia Ranibizumab is a monoclonal antibody Fab fragment derived from the same parent antibody as bevacizumab (Avastin) but engineered for higher affinity to VEGF-A and shorter systemic half-life — properties that made it the first anti-VEGF agent approved for intravitreal injection in retinal disease. Reference-product Lucentis (Genentech/Roche/Novartis) has been the standard-of-care anti-VEGF for neovascular AMD since 2006, though its dominance has been progressively challenged by aflibercept (Eylea, Regeneron) and more recently by faricimab (Vabysmo, Roche). Ranluspec (ranibizumab-hkdz) enters as an INTERCHANGEABLE biosimilar — the FDA's higher regulatory bar that permits pharmacy-level substitution without prescriber intervention (vs. non-interchangeable biosimilars that require prescriber sign-off). It joins other interchangeable ranibizumab biosimilars (Byooviz, Cimerli) in a maturing biosimilar landscape.
Source: Wikipedia · CC BY-SA
Topic biosimilars
