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Biosimilars of bevacizumab Posted 02/06/2014

Last update: 13 October 2017

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

The originator product, Roche’s Avastin (bevacizumab), was approved by the US Food and Drug Administration (FDA) in February 2004 and by the European Medicines Agency (EMA) in January 2005 [1]. Avastin had 2016 sales of CHF 6.8 billion (Euros 5.95 billion) making it a popular target for biosimilar developers, see Table 1.

The patents on Avastin will expire in the US in July 2019 and in Europe in January 2022 [1]. There are estimated to be around 15 biosimilars of bevacizumab in development [2], of which just a few are presented below, see Table 1.

Table 1: Biosimilars and non-originator biologicals* of bevacizumab in development

Company name, Country

Product name

Stage of development

Amgen/Allergan, USA

Mvasi (ABP 215)

Phase III trial completed in September 2015 [3]. Submitted to FDA in November 2016 [4] and to EMA in December 2016 [5]. Approved by FDA in September 2017

Apotex (Apobiologix), Canada

-

Biosimilar in pipeline – under clinical development

AstraZeneca/Fujifilm Kyowa Kirin Biologics, USA/Japan

FKB238

50:50 joint venture established August 2015. Phase I trial started in November 2014 [7]

Aurobindo Pharma, India*

-

Acquired four biosimilars from TL Biopharmaceutical AG in February 2017 [8]

Biocad, Russia*

BCD-021

Phase III trials in lung cancer completed in November 2015. Phase III trial in wet AMD expected to be completed in February 2017 [9].  Approved in Russia in December 2015 [10]

BioXpress Therapeutics, Switzerland

-

In pipeline

Boehringer Ingelheim, Germany

BI 695502

Phase III trial in lung cancer expected to be completed in March 2019 [11]. Positive results from phase III trial reported in November 2016 [12]

Celltrion, South Korea

CT-P16

In pipeline

Coherus, USA

CHS-5217

Preclinical [13]

Hetero (Lupin), India*

Cizumab

‘Similar biologic’ launched in India in July 2016 [14]

mAbxience, Spain (Argentina*)

-

Medicamento biológico similar approved in Argentina

Oncobiologics/Viropro, USA

ONS-1045

Biosimilar collaboration agreement signed in February 2013 for 6 biosimilars [15]. ONS-1045, met its primary and secondary endpoints in a phase I clinical trial in October 2015. Phase III trial expected to start in 2018.

Pfizer, USA

PF-06439535

Phase III trial in lung cancer started in February 2015 [11]

PlantForm, Canada

-

Clinical trials in humans expected to begin in 2014. Launch, in partnership with a pharmaceutical company, in world markets expected in 2016 [16]

Prestige Biopharma, Singapore

HD204

Phase I

Reliance Life Sciences, India*

Bevacirel

‘Similar biologic’ launched in India in July 2016 [14]

Samsung Bioepis (Biogen/Samsung)/Merck, South Korea/USA

SB8

Phase III trial in lung cancer ongoing (April 2016) [17]

AMD: Age-related macular degeneration; FDA: US Food and Drug Administration.

*See editors comment

Amgen looks set to be ready with their biosimilar well in advance of the patent expiry on Avastin, putting the biotech giant in a good position to be first on the market. In fact, the company already submitted an application for marketing approval for its bevacizumab biosimilar (ABP 215) to the FDA in November 2016 [4].

Editor's comment
It should be noted that 'non-originator biologicals' approved in Russia, ‘medicamento biológico similares’ approved in Argentina and ‘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 EU. 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 best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars on the horizon [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-on-the-horizon
3. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 2]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-bevacizumab-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-bevacizumab-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab biosimilar application submitted to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Biosimilars/News/Bevacizumab-biosimilar-application-submitted-to-EMA
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 13].. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-bevacizumab-biosimilar-Mvasi
7. GaBI Online - Generics and Biosimilars Initiative. AstraZeneca and Fujifilm Kyowa Kirin Biologics to collaborate on bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 2]. Available from: www.gabionline.net/Pharma-News/AstraZeneca-and-Fujifilm-Kyowa-Kirin-Biologics-to-collaborate-on-bevacizumab-biosimilar
8. GaBI Online - Generics and Biosimilars Initiative. Samsung BioLogics and Aurobindo investing in biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 14]. Available from: www.gabionline.net/Pharma-News/Samsung-BioLogics-and-Aurobindo-investing-in-biosimilars
9. GaBI Online - Generics and Biosimilars Initiative. Comparison of non-originator filgrastim with Neupogen finds no difference in neutropenia recovery periods [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 12]. Available from: www.gabionline.net/Biosimilars/Research/Comparison-of-non-originator-filgrastim-with-Neupogen-finds-no-difference-in-neutropenia-recovery-periods
10. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab non-originator biological approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 8]. Available from: www.gabionline.net/Biosimilars/News/Bevacizumab-non-originator-biological-approved-in-Russia
11. GaBI Online - Generics and Biosimilars Initiative. Pivotal clinical trials for bevacizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 2]. Available from: www.gabionline.net/Reports/Pivotal-clinical-trials-for-bevacizumab-biosimilars
12. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for etanercept and bevacizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-etanercept-and-adalimumab-biosimilars
13. 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 Dec 9]. Available from: www.gabionline.net/Biosimilars/Research/More-positive-phase-I-results-for-Coherus-pegfilgrastim-biosimilar
14. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab similar biologics launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 5]. Available from: www.gabionline.net/Biosimilars/News/Bevacizumab-similar-biologics-launched-in-India
15. GaBI Online - Generics and Biosimilars Initiative. Oncobiologics and Viropro make biosimilar deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 2]. Available from: www.gabionline.net/Biosimilars/News/Oncobiologics-and-Viropro-make-biosimilar-deal
16. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab made in tobacco plants [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 5]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-trastuzumab-made-in-tobacco-plants
17. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis starts phase III trial for bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 5]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-starts-phase-III-trial-for-bevacizumab-biosimilar

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Source: ClinicalTrials.gov, EMA, EU Clinical Trials Register

Comments (1)

Pfizer has biosimilar(PF-06439535) of bevacizumab on phase III posted 17/06/2015 - by zhaoshuyong

Pfizer has biosimilar(PF-06439535) of bevacizumab on phase III