The European Commission (EC) granted marketing authorization for ranibizumab biosimilar Rimmyrah on 5 January 2024. The biosimilar was developed by Qilu Pharma.
EC approval of ranibizumab biosimilar Rimmyrah
Biosimilars/News | Posted 07/03/2024 0 Post your comment
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.
Related articles
FDA approves first interchangeable ranibizumab biosimilar
Byooviz: first ophthalmology biosimilar launches in US
Teva signs deal with Bioeq for ranibizumab biosimilar FYB201
LATIN AMERICAN FORUM View the latest headline article: El recorrido del biológico de continuación Pectuna (pertuzumab) en Irán Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
FORO LATINOAMERICANO Ver el último artículo de cabecera: El recorrido del biosimilar de seguimiento de pertuzumab de Pectuna en Irán !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. |
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
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.
Research
Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
Biosimilars in inflammatory bowel disease: are we ready for multiple switches
General
Humira's resilience in the face of biosimilar competition
Boehringer Ingelheim to expand access to adalimumab biosimilar
Comments (0)
Post your comment