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RA and psoriasis for ABP 501, without any primary RCT data existing in IBD,
though these trials are now underway. Health Canada, on the other hand, denied
approval of extrapolation to IBD indications, given their concerns regarding simi-
larity of the mechanisms of action of TNF in the pathophysiology of disease in
IBD, compared to RA and AS. The FDA has not issued guidance regarding the
issue of interchangeability where substitution of the biosimilar may occur without
the consent or even knowledge of the prescribing physician. A number of critical
study design issues will need to be established before valid interchangeability tri-
als can be performed. There is already significant resistance by professional soci-
eties around the world to the practice of interchangeability in the absence of
IBD-specific controlled trials, and the issue of immunogenicity is of significant
concern. The biosimilars have the potential for significant cost savings and increas-
ing patient access. However long- term follow-up and randomized controlled trials
specifically in IBD will determine whether comparable efficacy, safety, and immu-
nogenicity will lead to patient benefit by reducing cost and increasing access.
Author Responsibilities Christina Ha—manuscript writing and editing; she has approved the
final manuscript for submission.
Asher Kornbluth—manuscript writing and editing; he has approved the final manuscript for
submission.
Disclosures Christina Ha—AbbVie: Advisory Board, Consultant; Takeda: Consultant.
Asher Kornbluth—Abbvie: Speaker’s Bureau, Advisory Board,Research Support; Janssen:
Speaker’s Bureau, Advisory Board, Research Support; Pfizer: Advisory Board, Research Support;
Takeda: Speaker’s Bureau, Advisory Board, Research Support
References
- Norman P. Humira: the impending patent battles over adalimumab biosimilars. Pharm Pat
Anal. 2016;5:141–5. - Food Drug Administration, Biologics price competition and innovation act. http://www.fda.
gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ucm216146.pdf. - FDA’s overview of the regulatory guidance for the development and approval of biosimi-
lar products in the US.http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/
HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/
Biosimilars/UCM428732.pdf. - Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to
demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator inflix-
imab when coadministered with methotrexate in patients with active rheumatoid arthritis: the
PLANETRA study. Ann Rheum Dis. 2013;72:1613–20. - Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, pro-
spective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator
infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis.
2013;72:1605–12. - Food & Drug Administration.Guidance for industry: clinical pharmacology data to support a
demonstration of biosimilarity to a reference product. http://www.fda.gov/downloads/drugs/
C.Y. Ha and A. Kornbluth