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Biosimilars of adalimumab Posted 03/10/2014

Last update: 30 September 2016

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumor necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

The originator product, AbbVie’s Humira (adalimumab), was approved by the US Food and Drug Administration (FDA) in December 2002 and by the European Medicines Agency (EMA) in September 2003 [1]. Humira had worldwide sales of US$14 billion in 2015.

The patents on Humira will expire in the US in December 2016 and in Europe in April 2018 [1]. Some of the adalimumab biosimilars in development are presented in Table 1.

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

Company name, Country

Product name

Stage of development

AET BioTech/BioXpress Therapeutics, Germany/Switzerland

-

Biosimilar in pipeline. Development partnership announced in November 2012 [2]

Amgen, USA

ABP 501

Phase III trials ongoing in the European Union and the US [3]. Positive results from phase III trial in arthritis announced in February 2015 [4]. Approved by US FDA in September 2016 [5] and submitted to EMA for approval in December 2015 [6]

Boehringer Ingelheim, Germany

BI695501

Phase I studies in Belgium and New Zealand completed in 2012 and 2015 [7,8]. Phase III study expected to be completed in December 2016 [8].

Coherus Biosciences, USA

CHS-1420

Pharmacokinetic study completed in August 2014 [9]

Fujifilm/Kyowa Hakko Kirin (Fujifilm Kyowa Kirin Biologics), Japan

FKB327

50:50 joint venture announced in March 2012. Phase III clinical trial ongoing [10]

LG Life Sciences/Mochida Pharmaceutical, South Korea/Japan

LBAL

Phase I trial expected to be completed in March 2015 [11]

Momenta Pharmaceuticals/Baxalta (Baxter spin-off), USA

M923

Phase III clinical trial started in October 2015 [12]. Collaborating with Baxter on six biosimilars [13]

Merck KGaA (Merck Group), Germany

MSB11022

Phase III clinical trial started in March 2016. Expected to be completed in September 2017 [14].

Oncobiologics/Viropro, USA

ONS-3010

Phase I PK study completed in February 2015 [15]. One of six monoclonal antibody biosimilars for which the companies are collaborating [16].  Phase III trial expected to start in 2016.

Pfizer, USA

PF-06410293

Phase I study expected to be completed in January 2014 [17]

PlantForm, Canada

-

Clinical trials in humans began in 2014. Launch, in partnership with a pharmaceutical company, in world markets expected in 2016 [18]

Samsung Bioepis, South Korea

SB5

Phase I study completed. Phase III study expected to be completed in May 2015 [19]. Submitted to EMA for approval in July 2016 [20]

Sandoz, Switzerland

GP2017

Started phase III clinical trial in December 2013 [21], expected to be completed in April 2016.

Torrent Pharmaceuticals, India*

Adfrar

Similar biologic’ launched in India in January 2016 [22]

Zydus Cadila, India*

Exemptia

Similar biologic’ launched in India in December 2014 [23]

PK: pharmacokinetic.
*See editor’s comment

There appear to be several front runners in the race to biosimilar adalimumab in Europe/the US. Momenta Pharmaceuticals (Momenta) and generics maker Sandoz have both completed phase III trials with their candidates [13, 21]. But leading the race are biotech major Amgen and Samsung Bioepis (a Biogen and Samsung joint venture), who have both submitted their marketing applications to EMA for approval [6, 20]. And FDA has approved Amgen’s biosimilar adalimumab in September 2016 [5].

Sandoz already markets biosimilar somatropin (Omnitrope), biosimilar epoetin alfa (Binocrit) and biosimilar filgrastim (Zarzio) in countries across Europe [24] and elsewhere. Omnitrope, approved under the 505(b)(2) pathway of the Hatch-Waxman Act, is also marketed in the US.

Indian generics maker Zydus Cadila launched its similar biologic in India in December 2014 under the brand name Exemptia (adalimumab). The company claims that it is ‘the first company anywhere in the world to launch a biosimilar of adalimumab’ [23].

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 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. The latest biosimilars agreements [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/News/The-latest-biosimilars-agreements 
3. GaBI Online - Generics and Biosimilars Initiative. Amgen starts another phase III trial for biosimilar adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/News/Amgen-starts-another-phase-III-trial-for-biosimilar-adalimumab 
4. GaBI Online - Generics and Biosimilars Initiative. Positive phase III data for Amgen adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 20]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-data-for-Amgen-adalimumab-biosimilar 
5. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 30]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar 
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilar adalimumab application submitted to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-adalimumab-application-submitted-to-EMA
7.   GaBI Online - Generics and Biosimilars Initiative. Development of biosimilars for rheumatology [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/Research/Development-of-biosimilars-for-rheumatology 
8.   GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for adalimumab biosimilar  [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-results-for-adalimumab-biosimilar 
9.   GaBI Online - Generics and Biosimilars Initiative. Adalimumab biosimilar has comparable pharmacokinetics to Humira [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 20]. Available from: www.gabionline.net/Biosimilars/Research/Adalimumab-biosimilar-has-comparable-pharmacokinetics-to-Humira
10.   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 9]. Available from: www.gabionline.net/Pharma-News/AstraZeneca-and-Fujifilm-Kyowa-Kirin-Biologics-to-collaborate-on-bevacizumab-biosimilar 
11.   GaBI Online - Generics and Biosimilars Initiative. LG Life Sciences and Mochida make deal for adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 20]. Available from: www.gabionline.net/Biosimilars/News/LG-Life-Sciences-and-Mochida-make-deal-for-adalimumab-biosimilar
12.   GaBI Online - Generics and Biosimilars Initiative. Baxalta and Momenta start phase III trial for adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 16]. Available from: www.gabionline.net/Biosimilars/News/Baxalta-and-Momenta-start-phase-III-trial-for-adalimumab-biosimilar
13.   GaBI Online - Generics and Biosimilars Initiative. Baxter and Momenta make biosimilars deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/News/Baxter-and-Momenta-make-biosimilars-deal
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16.   GaBI Online - Generics and Biosimilars Initiative. Oncobiologics and Viropro make biosimilar deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/News/Oncobiologics-and-Viropro-make-biosimilar-deal 
17.   GaBI Online - Generics and Biosimilars Initiative. Pfizer to start trial for biosimilar adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/News/Pfizer-to-start-trial-for-biosimilar-adalimumab 
18. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab made in tobacco plants [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 12]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-trastuzumab-made-in-tobacco-plants
19. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for Samsung Bioepis biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-Samsung-Bioepis-biosimilars
20.   GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis adalimumab biosimilar submitted to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 12]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-adalimumab-biosimilar-submitted-to-EMA
21.   GaBI Online - Generics and Biosimilars Initiative. Sandoz starts phase III biosimilar adalimumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-starts-phase-III-biosimilar-adalimumab-trial
22. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
23.  GaBI Online - Generics and Biosimilars Initiative. Adalimumab similar biologic launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 26]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-similar-biologic-launched-in-India
24.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 

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Source: EMA, ClinicalTrials.gov, US FDA

Comments (1)

Biosimilars of adalimumab/ Zydus Cadila posted 19/12/2014 - by Sandeep

Zydus Cadila launched a biosimilar for this drug in India in Dec 2014. Should that not be added to this page?