Ranibizumab was developed by Genentech and marketed by them in the United States, and elsewhere by Novartis,[15] under the brand name Lucentis.[12][15][16] Ranibizumab (Lucentis) was approved for medical use in the United States in June 2006,[16][12] and in the European Union in January 2007.
In the United States, ranibizumab 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.[12][17]
In the European Union, ranibizumab is indicated 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 neovascularisation.[13][2][4]
It is used for age-related wet macular degeneration.[18] Its effectiveness is similar to that of bevacizumab[19][20] and aflibercept.[21] A 2023 systematic review update found that while ranibizumab and bevacizumab provide similar functional outcomes in diabetic macular edema, there is low-certainty evidence suggesting that ranibizumab is more effective in reducing central retinal thickness than bevacizumab.[22]
A 2014 Cochrane review did not find a difference between bevacizumab and ranibizumab in deaths or total severe side effects when used for macular degeneration.[23] There, however, was not a lot of evidence, and thus this conclusion is not that certain.[23]
Ranibizumab does appear to result in a lower risk of stomach and intestinal problems.[23] It is also associated with a low rate of eye related side effects.[24]
Serious adverse events related to the injection procedure occurred with an incidence rate of less than 1% and included endophthalmitis, retinal detachment, and traumatic cataracts. Other serious ocular adverse events observed among ranibizumab-treated patients (incidence rate < 1%) included intraocular inflammation and blindness.[25]
Its effectiveness is similar to that of bevacizumab.[19][28] Its rates of side effects also appear similar.[23] However, ranibizumab typically costs $2,000 a dose, while the equivalent dose of bevacizumab typically costs $50.[29][30][31][32]
Genentech offered secret rebates to about 300 ophthalmologists in an apparent inducement to get them to use more ranibizumab rather than the less expensive bevacizumab. In 2008, bevacizumab cost Medicare only $20 million for about 480,000 injections, while ranibizumab cost Medicare $537 million for only 337,000 injections.[33] A small study showed no superior effect of ranibizumab versus bevacizumab in direct comparison.[34] The initial results of the larger Comparison of Age-related Macular Degeneration Treatments Trials (CATT) found that the two drugs "had equivalent effects on visual acuity when administered according to the same schedule;" however, serious adverse events were more common in the bevacizumab arm of the trial.[30]
According to a 2012 meta-analysis, the results of several subsequent head-to-head trials found that the two therapies performed equally at restoring visual acuity.[35][36] A 2012 meta-analysis focused specifically on safety issues concluded that the rates of several adverse events were higher with bevacizumab, although the absolute rates of ocular serious adverse events were low with both therapies: ocular adverse events were about 2.8 times as frequent with bevacizumab than with ranibizumab.[28]
Byooviz was approved for medical use in the European Union in August 2021.[2][37]
Ranibizumab-nuna (Byooviz) was approved for medical use in the United States in September 2021.[1][17]
Susvimo was approved for medical use in the United States in October 2021.[6][38]
In India, Lupin Limited received marketing approval for its biosimilar of Ranibizumab.[39]
In June 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) 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.[40] The applicant for this medicinal product is Midas Pharma GmbH.[40] Ranivisio was approved for medical use in the European Union in August 2022.[4][41]
Ranibizumab-eqrn (Cimerli) was approved for medical use in the United States in August 2022.[3][42]
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.[43] The applicant for this medicinal product is STADA Arzneimittel AG.[43] Ximluci was approved for medical use in the European Union in November 2022.[7][44]
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.[45] The applicant for this medicinal product is QILU PHARMA SPAIN S.L.[45] 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.[45]
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.[46][47][48]
^ abcd"Byooviz EPAR". European Medicines Agency. 23 June 2021. Archived from the original on 10 September 2021. Retrieved 9 September 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ abcd"Ranivisio EPAR". European Medicines Agency (EMA). 20 June 2022. Archived from the original on 6 October 2022. Retrieved 6 October 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ ab"Raniviz APMDS". Therapeutic Goods Administration (TGA). 8 January 2024. Archived from the original on 8 February 2024. Retrieved 7 March 2024.
^ abc"Ximluci EPAR". European Medicines Agency. 14 September 2022. Archived from the original on 13 March 2023. Retrieved 3 March 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ ab"AusPAR: Ranibizumab". Therapeutic Goods Administration (TGA). 9 December 2014. Archived from the original on 21 September 2021. Retrieved 20 September 2021.
^ ab"Byooviz APMDS". Therapeutic Goods Administration (TGA). 6 September 2022. Retrieved 7 March 2024.
^ ab"Lucentis EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 10 September 2021. Retrieved 9 September 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ ab"Ranivisio: Pending EC decision". European Medicines Agency. 22 June 2022. Archived from the original on 26 June 2022. Retrieved 26 June 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ ab"Ximluci: Pending EC decision". European Medicines Agency (EMA). 15 September 2022. Archived from the original on 19 September 2022. Retrieved 18 September 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ abc"Rimmyrah: Pending EC decision". European Medicines Agency. 10 November 2023. Archived from the original on 13 November 2023. Retrieved 5 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
N
Y (what is this?) (verify)
This article incorporates text from this source, which is in the public domain.
