Biosimilar Clinical Research: An Overview

One topic that is recently getting highlights is Biosimilar clinical research that is gaining prominence through increasing number of posters and oral presentations, as well as sponsored symposia and lectures. There are growing reports of real world experience from approved biosimilars though very few in numbers and of biosimilar clinical trials assessing the switch from an originator product to a biosimilar. As more and more biosimilars are reaching the market, some of the main areas of interest for clinicians is the effect on efficacy of switching or alternating treatments, and also considering the preference of payers towards less expensive biosimilars.

Examination Of Switching Data Between Biosimilars and Originator Drugs

Most of the present switching data come from infliximab, as its biosimilar Inflectra®/Remsima® was the first one of this type to reach the market. However, more data are coming from other biosimilars, like etanercept, adalimumab, or rituximab.

Moots RJ et al. reported the results of a MEDLINE/Web of Science search that identified 12 studies in several rheumatic diseases where healthy volunteers who received etanercept, infliximab, adalimumab, or rituximab switched between originator biologics and biosimilars. Overall the data showed that efficacy, safety and immunogenicity were not significantly affected by the switch.

The Real data regarding infliximab biosimilars were reported mainly from Nordic European countries, where the biosimilar prescriptions have overtaken those of the originator product Remicade. In Sweden, most of the patients were prescribed infliximab and were switched from the originator product. About 200 patients from 4 rheumatology departments in The Netherlands who agreed to switch from the originator infliximab to the biosimilar in the duration of 2015 have been followed for six months.

Thought vs. Reality

In the majority of the cases, no changes in efficacy, safety or immunogenicity are observed, but 23% discontinued the biosimilar due to perceived inefficacy or adverse events. The authors created a “nocebo” effect as a possible reason. Similar such data were obtained from the non-medical nationwide switch from originator infliximab to a biosimilar, which was conducted in Denmark.  In this case, even if disease activity appeared largely unaffected by the switch, 15% of patients stopped taking their treatment.

FDA Guidelines for Interchange of Biosimilars As Expected This Year

The switching design commonly employed so far has been mainly of transitioning patients from the originator product to the biosimilar, either within a clinical trial or in the clinical practice. However more sophisticated designs are likely to be applied in new biosimilar clinical trials, and multiple switches say it, between the biosimilars are about to take place in the recent future. The FDA is expected to supposed its guidelines on interchangeability between originator and biosimiliar drugs, and what evidence would be required to support claims of these interchangeabilities.

Hope this to make an immediate impact on the prevalence and design of biosimilar clinical trials. Until next, the Worldwide Clinical Trials experts will continue their working closely with certain regulatory entities and the sponsors to explore the various promises of biosimilars across the therapeutic areas of focus.

We conclude the discussion here. Stay connected with us this space for more discussions.

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