Ranluspec (ranibizumab biosimilar) / Lupin, Sandoz - LARVOL DELTA

Real-World Comparison of Biosimilar Ranibizumab (Ranieyes) and Innovator Ranibizumab (Lucentis/Accentrix) Across Multiple Retinal Vascular Diseases (The BRIO Study). (PubMed, Pharmaceuticals (Basel)) - "Serious ocular and systemic adverse events were rare in both groups, and no new safety signal emerged. In this large real-world cohort, the biosimilar ranibizumab Ranieyes showed outcomes broadly comparable to innovator ranibizumab across the major retinal disease subgroups, although these findings should be interpreted as observational comparative evidence rather than formal proof of equivalence."

Journal • Real-world evidence • Age-related Macular Degeneration • Cardiovascular • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Lupin receives USFDA approval for ranluspec biosimilar referencing Lucentis (CNBC-TV18) - "Both the vial and pre-filled syringe formats have been approved in the two strengths available for Lucentis: 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL). Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A....The drug is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularisation."

FDA approval • Diabetic Macular Edema • Diabetic Retinopathy • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Sandoz confirms European Commission approval for Ranluspec (ranibizumab), further strengthening overall biosimilars leadership and position in ophthalmology (Sandoz Press Release) - "Ranluspec is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularization...The approval paves the way for an expected launch of Ranluspec in the second half of 2026."

EMA approval • Launch Europe • Diabetic Macular Edema • Diabetic Retinopathy • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

...new medicines recommended for approval (European Medicines Agency) - "Ranluspec (ranibizumab), for the treatment of neovascular age-related macular degeneration, visual impairment and other retinopathies."

CHMP • Diabetic Macular Edema • Diabetic Retinopathy • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Study to Compare Efficacy and Safety of LUBT010 and Lucentis® in Patients With Neovascular AMD (clinicaltrials.gov) - P3 | N=600 | Completed | Sponsor: Lupin Ltd. | Recruiting ➔ Completed | Trial completion date: Oct 2022 ➔ May 2024 | Trial primary completion date: Oct 2022 ➔ May 2024

Trial completion • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration