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Biosimilars of bevacizumab Posted 02/06/2014

Last update: 13 July 2018

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) before the advent of biosimilars, 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 [6] and by EC in January 2018 [7]

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 [8]

Aurobindo Pharma, India*

-

Acquired four biosimilars from TL Biopharmaceutical AG in February 2017 [9]

Biocad, Russia*

BCD-021

Phase III trial in lung cancer completed in November 2014. Phase III trial in wet AMD withdrawn [10]. Non-originator biological approved in Russia in December 2015 [11]

BIOCND, South Korea

BCD500

Phase III trial ongoing

Biocon, India*

Krabeva

‘Similar biologic’ launched in India in November 2017 [12]. Phase I PK study in Europe completed. Phase III trial in NSLC ongoing [12]

BioXpress Therapeutics, Switzerland

-

In pipeline

Boehringer Ingelheim, Germany

BI 695502

Phase III trial in lung cancer expected to be completed in March 2019 [13]. Positive results from phase III trial reported in November 2016 [14]

Celltrion, South Korea

CT-P16

In pipeline

Coherus, USA

CHS-5217

Preclinical [15]

Dr Reddy’s Laboratories, India*

DRZ_BZ

Phase III

Hetero (Lupin), India*

Cizumab

‘Similar biologic’ launched in India in July 2016 [16]

mAbxience, Spain (Argentina*)

Bevax

Medicamento biológico similar approved in Argentina [17]. Scientific advice obtained from EMA and FDA and clinical trials completed in 2017

Oncobiologics/Viropro, USA

ONS-1045

Biosimilar collaboration agreement signed in February 2013 for 6 biosimilars [18]. 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 [13]

PlantForm, Canada

-

Clinical trials in humans expected to begin in 2014. Launch, in partnership with a pharmaceutical company, in world markets expected in 2016 [19]

Prestige Biopharma, Singapore

HD204

Phase I

Reliance Life Sciences/Lupin, India*

Bevacirel

‘Similar biologic’ launched in India in July 2016 [16]

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

SB8

Phase III trial in lung cancer ongoing (April 2016) [20]

AMD: Age-related macular degeneration; EMA: European Medicines Agency; EC: European Commission; FDA: US Food and Drug Administration; PK: pharmacokinetics; NSLC: non-small-cell lung cancer.

*See editors comment

Amgen is ready with its 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 has already received marketing approval for its bevacizumab biosimilar, Mvasi (ABP 215), from both the FDA [6] and the EC [7].

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 biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
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. EC approval for bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-bevacizumab-biosimilar-Mvasi
8. 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
9. 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
10. 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
11. 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
12.  GaBI Online - Generics and Biosimilars Initiative. Bevacizumab similar biologic launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from: www.gabionline.net/Biosimilars/News/Bevacizumab-similar-biologic-launched-in-India
13. 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
14. 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
15. 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
16. 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
17.  GaBI Online - Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from: www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America
18. 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
19. 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
20. 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 (3)

Response to ‘New bevacizumab biosimilar approved in Argentina’ posted 18/09/2018 - by Louis B, GaBI Online Editorial Office

Thank you for your valuable comments and insight received on 5 August 2018, we have followed-up on your suggestion and researched the issue further. We have added this news on the website and will make the necessary addition in the next update of the article ‘Biosimilars of bevacizumab’. We very much appreciate your kind feedback. Thank you for your interest in GaBI, and please continue with your valuable comments to GaBI Online. Best Regards, Louis

New bevacizumab biosimilar approved in Argentina posted 12/09/2018 - by Lucas

First posted 5/8/2018 ---- Lumiere - a bevacizumab biosimilar - approved for intravitreal use for age macular degeneration in Argentina.

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