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Biosimilars of rituximab Posted 27/02/2015

Last update: 14 April 2017

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

The originator product, Roche’s MabThera/Rituxan (rituximab), was approved by the US Food and Drug Administration (FDA) in November 1997 and by the European Medicines Agency (EMA) in June 1998 [1]. MabThera/Rituxan had sales of CHF 7.05 billion (Euros 6.38 billion) in 2015, therefore, many companies are working on biosimilars of the drug, see Table 1.

The patents on MabThera/Rituxan expired in the US in September 2016 and in Europe in February 2013 [1]. Some of the rituximab biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

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

Company name, Country

Product name

Stage of development

Amgen, USA

ABP 798

Biosimilar in active development, according to Amgen’s Form 10-K for 2013. One of four biosimilars for oncology indications that Amgen is developing in collaboration with Actavis [2]

Apotex (Apobiologix), Canada

-

Biosimilar in pipeline

Biocad, Russia*

AcellBia

Non-originator biological approved in Russia in April 2014 [3]

BioXpress Therapeutics, Switzerland

-

Biosimilar in pipeline [4]

Boehringer Ingelheim, Germany

BI 695500

Phase I and III trials expected to be completed in June and August 2015, respectively, but halted in October 2015 [5]

Celltrion/Hospira (Pfizer), South Korea/USA

Truxima (CT‑P10)

Phase I trial completed [6]. Phase III trials for RA and lymphoma expected to be completed in January 2017 and February 2017/March 2018, respectively. Collaborating with Teva in US and Canada [7]. Approved by Korean MFDS in November 2016 [8]. Positive phase III trial results reported in December 2016 [9]. Approved by EC in February 2017 [10]

Dr Reddy’s Laboratories, India*

Reditux

Reditux marketed in Bolivia, Chile, India and Peru [11, 12]

Hetero Group, India*

Maball

‘Similar biologic’ approved in India in August 2015 [13]

iBio, USA

-

Rituximab produced in non-transgenic green plants. Alliance made with GE Healthcare in 2012 [14]

Intas Biopharmaceuticals, India*

MabTas

‘Similar biologic’ approved in India in February 2013 [12]

JHL Biotech, Taiwan*

JHL1101

Phase I PK/PD trial started in February 2016. First patient dosed in a European trail of JHL1101 in March 2017. Made deal with Sanofi giving Sanofi rights to commercialize JHL1101 in China

Laboratorio Elea, Argentina*

Novex

Medicamento biológico similar approved in Argentina in October 2013

Mabion, Poland/Mylan, India*

MabionCD20

Phase III trial in lymphoma expected to be completed in June 2016 [15]. Agreement signed with Mylan to commercialize MabionCD20 in EU and non-EU Balkan states in November 2016 [16]

Oncobiologics/Viropro, USA

-

Biosimilar in development; one of six monoclonal antibody biosimilars for which the companies are collaborating [17]

Pfizer, USA

PF-05280586

Phase I/II trial in RA completed, extension study and phase III trial in lymphoma expected to be completed in August 2015 and November 2016, respectively

Probiomed, Mexico*

Kikuzubam

Kikuzubam marketed in Bolivia, Chile, Mexico and Peru [11]

Samsung BioLogics, South Korea

SAIT101

Phase III trial in RA halted in 2012 [18]

Sandoz, Switzerland

GP2013

Phase I trial in Japanese NHL patients, phase I/II trial in RA and phase III trial in lymphoma expected to be completed in March 2015, November 2015 and December 2017, respectively. Submitted to EMA for approval in May 2016 [19]

Shanghai Henlius Biotech, China*

HLX01

Phase III trial started in March 2015

Stada Arzneimittel, Germany

-

Made a deal with Gedeon Richter in 2011 for rituximab [20]

Teva Pharmaceutical Industries/Lonza, Israel/Switzerland

TL011

Phase III trial of TL011 halted in October 2012 [21]. Biosimilars collaboration ended in July 2013 [22]

Torrent Pharmaceuticals/ Reliance Life Sciences, India*

-

Exclusive licensing agreement announced in December 2014 for adalimumab, cetuximab and rituximab ‘similar biologics’ [23]

Zenotech Laboratories, India*

Rituximab

‘Similar biologic’ approved in India in February 2013 [12]

PK: pharmacokinetics; PD: pharmacodynamics; RA: rheumatoid arthritis; NHL: Non-Hodgkin’s Lymphoma; MFDS: Ministry of Food and Drug Safety.
*See editor’s comment 

The fact that the patents on the originator product, Roche’s MabThera/Rituxan (rituximab), already expired in Europe in February 2013, is perhaps spurring development and explains the many companies that are working on biosimilars of rituximab.

Editor’s comment
It should be noted that non-originator biologicals approved in Russia, similar biologics approved in India, biocomparables approved in Mexico, copy biologicals approved in China and medicamento biológico similares approved in Argentina 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 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. Amgen expands biosimilars programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/News/Amgen-expands-biosimilars-programme 
3. GaBI Online - Generics and Biosimilars Initiative. Rituximab non-originator biological approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-non-originator-biological-approved-in-Russia 
4. BioXpress Therapeutics. Biosimilar pipeline [homepage on the Internet]. [cited 2015 Feb 27]. Available from: www.bioxpress.com/#!pipeline/c6gz
5. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim stops biosimilar rituximab development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 30]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-stops-biosimilar-rituximab-development
6. GaBI Online - Generics and Biosimilars Initiative. Phase I study shows equivalence of biosimilar rituximab and MabThera [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/Research/Phase-I-study-shows-equivalence-of-biosimilar-rituximab-and-MabThera
7. GaBI Online - Generics and Biosimilars Initiative. Teva and Celltrion to partner on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 14]. Available from: www.gabionline.net/Biosimilars/News/Teva-and-Celltrion-to-partner-on-biosimilars
8. GaBI Online - Generics and Biosimilars Initiative. Biosimilar rituximab approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 14]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-South-Korea
9. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for Celltrion’s rituximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 14]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-Celltrion-s-rituximab-biosimilar
10. GaBI Online - Generics and Biosimilars Initiative. EC approval for first cancer biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 14]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-first-cancer-biosimilar-Truxima
11. 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 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America 
12. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India 
13. GaBI Online - Generics and Biosimilars Initiative. Rituximab 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/Rituximab-similar-biologic-launched-in-India
14. GaBI Online - Generics and Biosimilars Initiative. iBio and GE Healthcare form new global alliance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/News/iBio-and-GE-Healthcare-form-new-global-alliance 
15. GaBI Online - Generics and Biosimilars Initiative. Mabion starts phase III trial for rituximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/News/Mabion-starts-phase-III-trial-for-rituximab-biosimilar 
16. GaBI Online - Generics and Biosimilars Initiative. Mabion signs agreement with Mylan for rituximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [2017 Apr 25]. Available from: http://www.gabionline.net/Pharma-News/Mabion-signs-agreement-with-Mylan-for-rituximab-biosimilar
17. GaBI Online - Generics and Biosimilars Initiative. Oncobiologics and Viropro make biosimilar deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/News/Oncobiologics-and-Viropro-make-biosimilar-deal 
18. GaBI Online - Generics and Biosimilars Initiative. Samsung halts biosimilar rituximab development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/News/Samsung-halts-biosimilar-rituximab-development 
19. GaBI Online - Generics and Biosimilars Initiative. Rituximab biosimilar from Sandoz accepted for review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 9]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-biosimilar-from-Sandoz-accepted-for-review-by-EMA
20. GaBI Online - Generics and Biosimilars Initiative. Stada and Richter to collaborate on biosimilar development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/News/Stada-and-Richter-to-collaborate-on-biosimilar-development 
21. GaBI Online - Generics and Biosimilars Initiative. Teva halts phase III biosimilar rituximab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/News/Teva-halts-phase-III-biosimilar-rituximab-trial 
22. GaBI Online - Generics and Biosimilars Initiative. Teva and Lonza end biosimilars agreement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/News/Teva-and-Lonza-end-biosimilars-agreement 
23. GaBI Online - Generics and Biosimilars Initiative. Torrent licenses three ‘similar biologics’ from Reliance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Biosimilars/News/Torrent-licenses-three-similar-biologics-from-Reliance 

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Source: Amgen, Anmat, ClinicalTrials.gov

Comments (1)

Updated info posted 28/02/2015 - by Ak

There is also a Rituximab from Elea Laboratory (from Argentina) called Novex. Elea is part of chemo group from Spain.

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