Ranibizumab BS Intravitreal Injection Kit biosimilar secures additional indication in Japan for diabetic macular edema
Senju Pharmaceutical and Kidswell Bio said on January 13 that their biosimilar version of the ophthalmic vascular endothelial growth factor (VEGF) inhibitor Lucentis (ranibizumab) has added a new indication of diabetic macular edema
Codeveloped by the two companies, Ranibizumab BS Intravitreal Injection Kit 10 mg/mL “Senju” hit the Japan market as the first biosimilar in the ophthalmology space. It was originally approved for two indications: 1) age-related macular degeneration (AMD) with subfoveal choroidal neovascularization and 2) choroidal neovascularization in pathological myopia. Diabetic macular edema is now its third indication. Still, the product does not have two other indications carried by the original drug, marketed by Novartis, 1) macular edema secondary to retinal vein occlusion and 2) retinopathy of prematurity.
Lucentis patents expired in July 2020 in the US and in April 2022 in the EU.
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