The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use announced on 9 November 2023 that it had recommended granting of marketing authorization for Rimmyrah (ranibizumab), a biosimilar that references ophthalmology drug, Lucentis.
Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. It inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A) [1].
Ranibizumab can be used to treat macular degeneration by inhibiting VEGF, which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. The monoclonal antibody drug is indicated for the treatment of wet age-related macular degeneration (AMD), macular oedema, degenerative myopia and diabetes complications; all conditions of the eye causing vision loss [1].
The application for Rimmyrah was submitted by Qilu Pharma. The biosimilar is intended for the treatment of neovascular wet AMD, visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularisation (CNV).
Rimmyrah will be available as a 10 mg/mL solution for injection. EMA stipulates that this must be administered by an ophthalmologist experienced in administering intravitreal injections.
EMA has now approved four biosimilar versions of ranibizumab. Rimmyrah will join three other companies in competing in the European market, as shown in Table 1.
| Table 1: Biosimilar ranibizumab approved in Europe
|
| Product name
|
Active substance
|
Therapeutic area
|
Authorization date
|
Manufacturer/
Company name
|
| Byooviz
|
ranibizumab
|
Degenerative myopia
Diabetic retinopathy
Macular oedema
Wet macular degeneration
|
18 Aug 2021
|
Samsung Bioepis
|
| Ranivisio
|
ranibizumab
|
Diabetes complications
Diabetic retinopathy
Macular oedema
Wet macular degeneration
|
25 Aug 2022
|
Bioeq/Teva Pharma
|
| Rimmyrah
|
ranibizumab
|
Choroidal neovascularisation
Diabetic macular edema
Macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)
Proliferative diabetic retinopathy
Wet age-related macular degeneration
|
9 Nov 2023
|
Qilu Pharma
|
| Ximluci
|
ranibizumab
|
Diabetes complications
Diabetic retinopathy
Macular oedema
Wet macular degeneration
|
9 Nov 2022
|
Stada Arzneimittel /Xbrane Biopharma
|
Qilu is amongst the major pharmaceutical companies in China involved in the development of copy biologicals products, along with representative companies such as Henlius, Hisun, Innoventbio, Mabpharm [2].
Qilu has its bevacizumab copy biological, Ankeda, approved by China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), on 9 December 2023 [3]. Qilu initiated a phase III trial for denosumab copy biological in November 2019 [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Dec 12]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
2. GaBI Online - Generics and Biosimilars Initiative. Pharmaceutical companies in China manufacturing copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Dec 12]. Available from: www.gabionline.net/reports/pharmaceutical-companies-in-china-manufacturing-copy-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. China approves bevacizumab copy biological Ankeda [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Dec 12]. Available from: www.gabionline.net/biosimilars/news/china-approves-bevacizumab-copy-biological-ankeda
4. GaBI Online - Generics and Biosimilars Initiative. Qilu starts phase III trial for denosumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Dec 12]. Available from: www.gabionline.net/biosimilars/news/Qilu-starts-phase-III-trial-for-denosumab-copy-biological
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