Standardizing clinical trials for biosimilars

Biosimilars/Research | Posted 28/10/2016 post-comment0 Post your comment

Researchers from the University of Massachusetts, USA and Newcastle University, UK argue that clinical trial design should be standardized for future studies of biosimilars [1]. Indeed, they argue that a ‘standard clinical trial design be adopted for all biosimilars of a particular [originator biological] in a given disease’.

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Jonathan Kay and John Isaacs point out that phase III clinical trials comparing biosimilar TNF inhibitors with their originator biosimilars have employed different designs. They give the examples of the infliximab biosimilars Remsima/Inflectra (CT P13) and Flixabi/Renflexis (SB2), as well as the etanercept biosimilars Davictrel (HD203) and Benepali/Brenzys (SB4).

The authors have compiled a list of attributes of clinical trials for biosimilars that they feel could be standardized:

• Healthy subjects versus patients (in phase I)
• Inclusion and exclusion criteria
• Equivalence margins
• Primary endpoint (including timing of assessment)
• Secondary endpoints (including timing of assessment)
• Pharmacokinetic assays (endpoints compared and timing of assessment)
• Immunogenicity (assays used and timing of testing)
• Analysis of effects of immunogenicity on pharmacokinetics, efficacy and safety
• Definition of adverse events, for example, injection-site reactions
• Statistical analyses
• Cross-over designs beyond primary endpoint (in phase III)

Such standardization, according to Kay and Isaacs, ‘could be agreed upon and overseen by regulatory agencies around the world’. They add that ‘consistency across clinical trials should increase confidence in these more affordable biopharmaceuticals, both within the healthcare community and among patients’.

In the following series of two articles differences in clinical trials for biosimilars are discussed.

Conflict of interest
The authors of the research paper [1] reported conflicts of interest, including having received honoraria, research grants or consulting fees from pharmaceutical companies. For full details of the authors’ conflicts of interest, see the research paper [1].
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1. Kay J, Isaacs JD. Clinical trials of biosimilars should become more similar. Ann Rheum Dis. 2016 Aug 25. pii: annrheumdis-2015-208113. doi:10.1136/annrheumdis-2015-208113

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