On 6 August 2018 the European Medicines Agency (EMA) launched an open consultation on a guideline for a biopharmaceutics classification system (BCS)-based biowaivers. The aim of the guideline is to avoid duplication of research for pharmaceutical (and generic) products and ensure harmonisation of differentiated regional guidelines.
Biowaivers can be granted to (re)use data of the in vitro data as the bioequivalent of in vivo data. Consequently, duplication of research can be avoided, and thus unnecessary additional human testing.
Medical authorities, such as the EMA, use a BCS to categorise the drug substances. The BCS is divided into four classes. However, BCS based-biowaivers are not recognised worldwide for class I and III drugs. Therefore, pharmaceutical companies have to follow different approaches in different regions. The proposed guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide recommendations to support the waiver of bioequivalence studies. This will result in the harmonisation of differentiated regional guidelines and support streamlined global drug development.
BCS-based biowaivers may be used for different purposes, including to demonstrate bioequivalence between products in early clinical development, or in applications for generic drug products. Therefore, a BCS-based biowaiver has become an important and cost-saving tool in approval of generic drugs.
The consultation will be open for feedback until 6 February 2019 and can be sent to firstname.lastname@example.org.
The guideline for the BCS-based biowaivers is available here.