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Biosimilars of ranibizumab Posted 30/10/2015

Last update: 12 May 2017

Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab [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.

The originator product, blockbuster wet AMD treatment Lucentis (ranibizumab) marketed by Genentech (Roche)/Novartis, was approved by the US Food and Drug Administration (FDA) in June 2006 and by the European Medicines Agency (EMA) in January 2007 [1]. Lucentis had estimated global sales of approximately US$3.6 billion in 2015.

The patents on Lucentis will expire in the US in June 2020 and in Europe in 2022 [1]. Some of the ranibizumab biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of ranibizumab approved or in development

Company name, Country

Product name

Stage of development

Coherus, USA

CHS-3351

In pipeline [2]

Formycon/bioeq, Germany

FYB201

Phase III trial started in October 2015 [3]

Hospira (Pfizer)/Pfenex, USA

PF582

Entered into an agreement to exclusively develop and commercialize PF582 in February 2015 [4]. Pilot phase I/II study in AMD ongoing as of February 2015

Intas Biopharmaceuticals, India*

Razumab

‘Similar biologic’ launched in India in June 2015 [5]

Xbrane Biopharma, Sweden

Xlucane

Positive data from in vitro biosimilarity study comparing Xlucane versus Lucentis reported in February 2017 [6]

*See editor’s comment

Editor’s comment
It should be noted that similar biologics approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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References
1. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
2. GaBI Online - Generics and Biosimilars Initiative. More positive phase I results for Coherus pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 25]. Available from: www.gabionline.net/Biosimilars/Research/More-positive-phase-I-results-for-Coherus-pegfilgrastim-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Formycon starts phase III trial for ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 30]. Available from: www.gabionline.net/Biosimilars/News/Formycon-starts-phase-III-trial-for-ranibizumab-biosimilar
4.   GaBI Online - Generics and Biosimilars Initiative. Hospira and Pfenex to collaborate on ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 30]. Available from: www.gabionline.net/Biosimilars/News/Hospira-and-Pfenex-to-collaborate-on-ranibizumab-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Ranibizumab similar biologic launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 30]. Available from: www.gabionline.net/Biosimilars/News/Ranibizumab-similar-biologic-launched-in-India
6. GaBI Online - Generics and Biosimilars Initiative. Advances in teriparatide and ranibizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 12]. Available from: www.gabionline.net/Biosimilars/News/Advances-in-ranibizumab-and-teriparatide-biosimilars

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Source: ClinicalTrials.gov, EMA, US FDA

Comments (2)

Response to ‘Lucentis Biosimilar’ posted 03/06/2016 - by Louis B, GaBI Online Editorial Office

Thank you for your comment. The original content of ' Lucentis from Novartis ' was ambiguous, we have adjusted the content in question to clarify the details. Best Regards, Louis

Lucentis biosimilar posted 20/04/2016 - by Ns

Lucentis was not developed by Novartis. It was developed by Genentech. Please correct the information.