Biosimilar development: Optimizing PK/PD studies
Parexel experts from regulatory, Early Phase Clinical Unit (EPCU) and translational and genomic medicine discuss the need to conduct comparative efficacy trials (CET) in the development of biosimilars. Although the international regulatory trend (led by FDA and MHRA) is to waive the CET, the Committee on Healthcare Medicinal Products (CHMP) in Europe currently still requires such trials.
The waiver of CETs will undoubtedly result in greater emphasis on the quality and pharmacokinetic (PK) data. Therefore, based on two decades of Parexel’s experts’ practical experience with biosimilars PK/PD studies, the following aspects are discussed in this whitepaper:
A. Justifying the waiver of CETs in the development of biosimilars
B. Considerations for the design of PK/PD biosimilar studies
C. Navigating the potential confounding factors in the conduct of PK/PD biosimilar studies
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