The European Medicines Agency regulation of biosimilar production is based on the procedures that are in place for assessing manufacturing changes of originator biologics. Central to this is demonstrating that there are no significant clinical differences between a biosimilar and its reference biologic. In this video, Martin Dyer, DPhil, FRCP, FRCPath, explains that the step-wise approach to the regulation of biosimilars is no less stringent to originator biologics, but that the balance of data required is different.
Biological variability is inherent. Mapping out the batch-to-batch variability of rituximab over time, it is clear that biologics do not stay the same. However, this is not a cause for concern, as regulatory authorities continue to monitor the quality and functionality of the drug.
Here you can find some of the evidence, recommendations and practical considerations for the adoption of biosimilar monoclonal antibodies.
Biosimilars are typically approved for all of the indications of the originator brand. Extrapolation of clinical efficacy and safety data to other indications of the reference biologic not specifically studied during the clinical development of the biosimilar, is possible based on the overall evidence of comparability provided from the comparability exercise and with adequate justification. Although clinical data are an important part of the regulatory review for a biosimilar, comparability with the reference drug based on non-clinical studies is an inherent part of the pathway.
In addition to lymphoma, biosimilar rituximab has been indicated in the treatment of rheumatoid arthritis. Studies have found that biosimilar rituximab is equivalent to reference rituximab in terms of pharmacokinetics and efficacy, and highly similar in terms of efficacy and safety1–4.
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