The European Commission (EC) granted marketing authorization for ranibizumab biosimilar Rimmyrah on 5 January 2024. The biosimilar was developed by Qilu Pharma.
Ranibizumab is a monoclonal antibody drug indicated for the treatment of various retinal conditions including wet age-related macular degeneration (AMD), macular oedema, degenerative myopia and diabetes complications; all conditions of the eye causing vision loss [1]. The reference medicine for Rimmyrah is Genentech (Roche)/Novartis’s Lucentis.
The EC approval follows a positive opinion issued on 9 November 2023 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) [2].
In their ‘Overview’ of Rimmyrah the EMA states, ‘Rimmyrah is a medicine used to treat adults with certain sight problems caused by damage to the retina (the light-sensing layer at the back of the eye), and more specifically its central region, known as the macula. The macula provides the vision needed to see detail for everyday tasks such as driving, reading and recognising faces’.
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 [2].
Rimmyrah is indicated in adults 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).
Under the EC authorization, additional monitoring is required for the medicine. This means that it is monitored even more intensively than other medicines.
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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 2024 Mar 7]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of ranibizumab biosimilar Rimmyrah [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Mar 7]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-ranibizumab-biosimilar-rimmyrah
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