Biosimilars
Byooviz was authorized for medical use in the European Union in August 2021.[24][25]
Ranibizumab-nuna (Byooviz) was approved for medical use in the United States in September 2021.[26][27]
In India, Lupin Limited received marketing approval for its biosimilar of Ranibizumab.[28]
In June 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ranivisio, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular edema or choroidal neovascularization, and proliferative diabetic retinopathy. The applicant for this medicinal product is Midas Pharma GmbH.[29] Ranivisio was authorized for medical use in the European Union in August 2022.[30][31]
Ranibizumab-eqrn (Cimerli) was approved for medical use in the United States in August 2022.[32][33]
In September 2022, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ximluci, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularization. The applicant for this medicinal product is STADA Arzneimittel AG.[34] Ximluci was authorized for medical use in the European Union in November 2022.[35][36]
In November 2023, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rimmyrah, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularization. The applicant for this medicinal product is QILU PHARMA SPAIN S.L.[37] Rimmyrah is a biosimilar medicinal product that is highly similar to the reference product Lucentis (ranibizumab), which was authorized in the EU in January 2007.[37] Rimmyrah was authorized for medical use in the European Union in January 2024.[38][39]
In January 2024, Sandoz signed an agreement to acquire ranibizumab-eqrn, the biosimilar version of ranibizumab branded as Cimerli from Coherus BioSciences, Inc. for an upfront cash purchase payment of US$170 million.[40][41][42]
In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Epruvy, intended for the treatment of neovascular (wet) age-related macular degeneration, 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 applicant for this medicinal product is Midas Pharma GmbH. Epruvy is a biosimilar medicinal product and is a duplicate of Ranivisio.[43] Epruvy was authorized for medical use in the European Union in September 2024.[43][44]
Ranibizumab-leyk (Nufymco) was approved for medical use in the United States in December 2025.[2] It is indicated for the treatment of neovascular (wet) age-related macular degeneration; macular edema following retinal vein occlusion; diabetic macular edema; diabetic retinopathy; and myopic choroidal neovascularization.[2]
In December 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ranluspec, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularisation. The applicant for this medicinal product is Lupin Europe GmbH. Ranluspec is a biosimilar medicinal product that is highly similar to the reference product Lucentis (ranibizumab).[45]
