Progress for Lucentis (ranibizumab) biosimilars in Europe and the US

Biosimilares/Novedades | Posted 28/10/2022 post-comment0 Post your comment

On 16 September 2022, Partners Stada Arzneimittel and Xbrane Biopharma announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Ximluci, a biosimilar candidate referencing Lucentis (ranibizumab). In addition, on 19 September 2022 in the US, Coherus BioSciences announced that from 3 October 2022, another ranibizumab biosimilar, Cimerli (ranibizumab-eqrn) will be commercially available. 

18794124_l

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). 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]. 

Lucentis is the originator product developed by Roche (Genentech) and is a blockbuster drug with global revenue of around US$3.4 billion in 2021, with just over 40% of sales in the US [2]. The originator’s US patent expired in June 2020 and the European patent is expiring in 2022 [3].  

Ximluci positive opinion in Europe
Ximluci has been recommended for approval in the European Union (EU) for the treatment of wet AMD, diabetic macular oedema (DME), diabetic retinopathy (PDR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV). The positive opinion will now be referred to the European Commission (EC) and a decision will be made on whether to grant marketing approval.

Cimerli US launch
Cimerli (also known as Ranivisio, Ongavia, FYB201 and CHS-201) was developed by Swiss biotechnology company Bioeq, a joint venture between Poland-based Polpharma Biologics and Germany-based Formycon [4]. 

US-based Coherus acquired rights to commercialize Bioeq’s ranibizumab biosimilar in the US in 2019 [5].

Cimerli (ranibizumab-eqrn) is the first interchangeable ranibizumab biosimilar approved by the US Food and Drug Administration for the treatment of neovascular (wet) (nAMD) and other serious retinal diseases. This covers all five indications of the originator biological Lucentis and includes diabetic macular oedema, diabetic retinopathy, macular oedema following retinal vein occlusion and myopic choroidal neovascularization [4].

The product has also been approved in Europe under the name Ranivisio [6] and in the UK as Ongavia [7].

Related articles
Canada approves ranibizumab biosimilar Byooviz

Phase III trial evidence used in approval of ranibizumab biosimilar Byooviz

Fresh partnerships announced for ranibizumab and trastuzumab biosimilars

LATIN AMERICAN FORUM

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Actualizaciones de las monografías de la Farmacopea Europea sobre productos bioterapéuticos

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

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Actualizaciones de las monografías de la Farmacopea Europea sobre productos bioterapéuticos

!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 2022 Oct 28]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
2. GaBI Online - Generics and Biosimilars Initiative. Byooviz: first ophthalmology biosimilar launches in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 28]. Available from: www.gabionline.net/biosimilars/news/byooviz-first-ophthalmology-biosimilar-launches-in-us
3. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal).2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 28]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ranibizumab-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Teva signs deal with Bioeq for ranibizumab biosimilar FYB201 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 28]. Available from: www.gabionline.net/pharma-news/teva-signs-deal-with-bioeq-for-ranibizumab-biosimilar-fyb201  
6. GaBI Online - Generics and Biosimilars Initiative.  EC approves ranibizumab biosimilar Ranivisio [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 28]. Available from: www.gabionline.net/biosimilars/news/ec-approves-ranibizumab-biosimilar-ranivisio
7. GaBI Online - Generics and Biosimilars Initiative. Lucentis biosimilars approved in the UK and Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Oct 28]. Available from: www.gabionline.net/biosimilars/news/lucentis-biosimilars-approved-in-the-uk-and-korea

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 © 2022 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
La FDA aprueba el biosimilar pegfilgrastim Stimufend
Approved-V13G05
Biosimilares/Novedades Posted 07/10/2022
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010