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Biosimilars of ranibizumab Posted 30/10/2015

Last update: 4 December 2020

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 [2]. 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

BIOCND, South Korea

BCD300

Phase 1 trial expected to be completed by end 2017. Marketing approval expected by 2020.

Biocure, South Korea

-

Preclinical [3]

Biocon/Samsung Bioepis, USA/South Korea

SB11

Collaborating with C-Bridge Capital (AffaMed Therapeutics) for copy biologicals in China [4]. Phase III trial in AMD ongoing. Submitted to EMA and FDA for approval in October and November 2020, respectively [5, 6].

Chong Kun Dang Pharmaceutical, South Korea

CKD 701

Preclinical

Coherus, USA

CHS-3351

Preclinical [2]

Formycon/Bioeq IP (Santo Holding/ Polpharma), Germany

FYB201

Phase III trial started in October 2015 [7]

Hospira (Pfizer)/Pfenex, USA

PF582

Entered into an agreement to exclusively develop and commercialize PF582 in February 2015 [8]. Pilot phase I/II study in AMD ongoing as of February 2015.

Intas Biopharmaceuticals, India*

Razumab

‘Similar biologic’ launched in India in June 2015 [9]

Polus Biopharm, South Korea

PDP807

Secondary target

Siam Bioscience, Thailand

SBS 7001

Positive data from in vitro biosimilarity study reported in September 2017

Xbrane Biopharma/Stada Arzneimittel, Sweden/Germany

Xlucane

Positive data from in vitro biosimilarity study comparing Xlucane versus Lucentis reported in February 2017 [10]. Study design for pivotal phase I/III clinical trial in wet AMD agreed with EMA and FDA [11]

AMD: age-related macular degeneration.
*See editor’s comment

Editor’s comment
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 but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that 'copy biologicals’ approved in China and ‘similar biologics’ approved in India might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
2. 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
3. GaBI Online - Generics and Biosimilars Initiative. Biocure developing five candidate biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/General/Biocure-developing-five-candidate-biosimilars 
4. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis makes deals for copy biologicals in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Pharma-News/Samsung-Bioepis-makes-deals-for-copy-biologicals-in-China
5. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for ranibizumab biosimilar from Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-ranibizumab-biosimilar-from-Samsung-Bioepis 
6. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-ranibizumab-biosimilar 
7. 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
8. 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
9. 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
10. 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
11. GaBI Online - Generics and Biosimilars Initiative. Licensing and co-development deals for ranibizumab and adalimumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Pharma-News/Co-development-deal-for-ranibizumab-biosimilar-Xlucane

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Source: ClinicalTrials.gov, EMA, US FDA

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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.