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The Trend in Biosimilar Development and Recent FDA Guidance

Statistical Consultancy Team

At the present time, the regulatory and drug development communities are adapting to a rising trend in biosimilar development in a number of therapeutic areas.

The regulatory framework for biosimilars in the US is still evolving; the number of biosimilars approved by the FDA in 2015 was 1, this rose to 4 in 2016 and is set to increase in 2017. The FDA is developing and consulting on draft guidance documents that will shape future trials, and at this early stage there are a number of legal issues to be agreed around licencing conditions, such as the period of exclusivity and the applicability of the biosimilar to all approved indications of the reference product. To put this in context with the European landscape, biosimilars have been approved and used in the EU for over a decade without highlighting any major safety concerns. As of April 2017, there were 28 approved biosimilars in the EU on 11 different biologics. However, there are aspects of the emerging FDA guidance that will almost certainly be reflected in the evolution of trial designs in the future, for products aimed at the US market.

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Topics: Regulatory Requirements, Pharmacokinetics and Pharmacodynamic, FDA, Clinical Study Design, European Medicines Agency, Bioequivalence, PK Analysis, Demonstrating Biosimilarity, Biosimilars

Pharmacokinetic Considerations of Biosimilars

Statistical Consultancy Team

When faced with the prospect of proving pharmacokinetic “equivalence” of a biosimilar to an innovator biologic, it may be natural to assume that standard bioequivalence study designs and analysis methods would be sufficient to meet the objectives of the study; after all, such study designs have been successfully employed for many years to bring generic drugs to market. However, there are a number of characteristics of biologics which set them apart from traditional generic drugs, as summarised in Table 1, below.

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Topics: Pharmacokinetics and Pharmacodynamic, Bioequivalence, PK Analysis, Demonstrating Biosimilarity, Biosimilars

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