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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