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Biosimilars for rheumatic diseases

Biosimilars/Research | Posted 29/09/2017 0 Post your comment

Biologicals have become central to the long-term management of many chronic diseases, including inflammatory rheumatic diseases. Biosimilars may help to fill an unmet need by improving patient access to effective biological treatments for chronic diseases. In light of these facts, authors from Norway reviewed biosimilars for rheumatic diseases [1].

Biologicals available for the treatment of rheumatic diseases include AbbVie’s Humira (adalimumab), Amgen/Pfizer’s Enbrel (etanercept), Johnson & Johnson and Merck’s Remicade (infliximab) and Roche’s MabThera/Rituxan (rituximab).

Biosimilars for all of these products have been approved by the European Medicines Agency (EMA). In the US, the US Food and Drug Administration (FDA) has approved biosimilars of filgrastim and infliximab. In addition, biosimilars or non-originator biologicals have also been approved for these products in other territories, see Table 1.

Table 1: Biosimilars and non-originator biologicals* of adalimumab, etanercept infliximab and rituximab approved or in development^# for rheumatic diseases

Active substance	Product name	Manufacturer/ Company name	Stage of development
Adalimumab	Adfrar	Torrent Pharmaceuticals	Approved in India [2]
	Amgevita/Solymbic (ABP 501)	Amgen	Approved in EU [3]
	Amjevita (ABP 501)	Amgen	Approved in the US [4]
	BAX 923	Baxalta (Shire)	Phase III
	CHS-1420	Coherus Biosciences	Phase III
	Cyltezo (BI 695501)	Boehringer Ingelheim	Approved in the US [4] Submitted to EMA [5]
	Exemptia (ZRC3197)	Zydus Cadila	Approved in India [2]
	FKB327	Fujifilm/Kyowa Hakko Kirin	Submitted to EMA [6]
	GP2017	Sandoz	Submitted to EMA [7]
	Imraldi (SB5)	Samsung Bioepis/Merck	Approved in EU [3]
	M923	Momenta Pharmaceuticals	Phase III
	MSB11022	Fresenius Kabi	Phase III
	PF-06410293	Pfizer	Phase III
Etanercept	Brenzys/Benepali (SB4)	Samsung Bioepis/Merck	Approved in EU [3] Approved in Australia [8] Approved in Canada [9] Approved in Korea [10]
	CHS-0214	Coherus Biosciences	Phase III
	Davictrel (HD203)	Hanwha Chemical/Merck	Approved in Korea [10]
	Erelzi (GP2015)	Sandoz	Approved in EU [3] Approved in the US [4] Approved in Canada [9]
	Etacept	Cipla	Approved in India [2]
	Etanar/Yisaipu	Shanghai CP Guojian Pharmaceutical	Approved in China Approved in Colombia [11]
	Intacept	Intas Pharmaceuticals	Approved in India [2]
	LBEC0101	LG Life Sciences (LG Chem) /Mochida Pharmaceutical	Submitted to PMDA [12]
	TuNEX (ENIA11)	Mycenax Biotech/ TSH Biopharm	Phase III
Infliximab	BOW015	Ranbaxy Laboratories/Epirus Biopharmaceuticals	Approved in India [2] Phase III
	Flixabi/ Renflexis (SB2)	Samsung Bioepis/Merck	Approved in EU [3] Approved in the US [4] Approved in Australia [8] Approved in Korea [10]
	Infliximab BS	Nippon Kayaku	Phase III
	NI-071	Nichi-Iko	Phase III
	PF-06438179	Pfizer/Sandoz	Submitted to FDA
	Remsima/ Inflectra/ Flammegis (CT-P13)	Celltrion/Hospira (Pfizer)	Approved in EU [3] Approved in the US [4] Approved in Australia [8] Approved in Canada [9] Approved in Japan [13] Approved in Korea [10] Approved in Russia [14] Approved in Latin America [11]
	STI-002	MabTech/Sorrento Therapeutics	Phase III
Rituximab	ABP 798	Amgen	Phase III
	AcellBia/ Usmal	Biocad	Approved in Russia [14] Approved in Latin America [11]
	HLX01	Shanghai Henlius Biotech	Phase III
	Maball	Hetero Group	Approved in India [2]
	MabionCD20	Mabion	Phase III
	MabTas	Intas Pharmaceuticals	Approved in India [2]
	Novex	mAbxience/Laboratorio Elea	Approved in Argentina [11]
	PF-05280586	Pfizer	Phase III
	Reditux	Dr Reddy’s Laboratories	Approved in India [2] Approved in Latin America [11]
	RituxiRel	Reliance Life Sciences	Approved in India [2]
	Rituximab	Zenotech Laboratories	Approved in India [2]
	Rixathon/ Riximyo (GP2013)	Sandoz	Approved in EU [3] Submitted to FDA
	Truxima/ Blitzima/ Ritemvia/ Rituzena (previously Tuxella) (CT-P10)	Celltrion	Approved in EU [3] Submitted to FDA Approved in Korea [10]
EMA: European Medicines Agency; EU: European Union; FDA: US Food and Drug Administration; PMDA: Pharmaceutical and Medical Devices Agency. ^#Phase III development or later *See editor’s comment

The authors outline the following key messages about biosimilars:

Biosimilar licensing [in Europe] is based on robust non-clinical and clinical evaluation of comparability with reference products.
The NOR-SWITCH study has shown that switching to biosimilars does not affect clinical outcomes in chronic diseases [15].
Biosimilars may enable improved access to biological treatments for chronic diseases, such as rheumatoid arthritis.

The authors point to questions about interchangeability, switching and automatic substitution as key challenges for the integration of biosimilars into everyday practice. The following series of two articles discusses some of these issues in the context of increasing access to biosimilars.

Conflict of interest
The authors of the research paper [1] reported conflicts of interest, including having received consulting fees, honoraria and having served as a consultant for pharmaceutical companies including AbbVie, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Orion Pharma, Pfizer, Roche and UCB.

For full details of the authors’ conflict of interest, see the research paper [1].

Editor’s comment
It should be noted that ‘non-originator biologicals’ approved in Russia, ‘similar biologics’ approved in India and ‘similar biotherapeutic products’ approved in Latin America 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.

Related articles
Barriers to access to biosimilars

Integrating biosimilars into clinical practice

References
1. Uhlig T, Goll GL. Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons. Rheumatology (Oxford). 2017;56(Suppl_4):iv49-iv62.
2. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
5. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-submits-biosimilar-adalimumab-application-to-both-EMA-and-FDA
6. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for adalimumab biosimilar from Fujifilm Kyowa Kirin Biologics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-adalimumab-biosimilar-from-Fujifilm-Kyowa-Kirin-Biologics
7. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and rituximab biosimilars from Sandoz accepted for review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-infliximab-biosimilars-from-Sandoz-accepted-for-review-by-EMA
8. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia
9. GaBI Online - Generics and Biosimilars Initiative. Subsequent entry biologics approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/General/Subsequent-entry-biologics-approved-in-Canada
10. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea
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 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America
12. GaBI Online - Generics and Biosimilars Initiative. Etanercept biosimilar submitted for approval in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/News/Etanercept-biosimilar-submitted-for-approval-in-Japan
13. GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab receives approval in Japan and Turkey [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-infliximab-receives-approval-in-Japan-and-Turkey
14. GaBI Online - Generics and Biosimilars Initiative. Non-originator infliximab approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/News/Non-originator-infliximab-approved-in-Russia
15. GaBI Online - Generics and Biosimilars Initiative. NOR-SWITCH study finds biosimilar infliximab not inferior to originator [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/Research/NOR-SWITCH-study-finds-biosimilar-infliximab-not-inferior-to-originator

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