The Bioequivalence Working Group for Generics (BEWGG) covers the application and interpretation of bioequivalence requirements as well as information and procedures for the assessment of bioequivalence.
The availability of quality generic medicines plays an increasingly important role in helping to address rising health care costs and in promoting access to essential medicines worldwide. This, however, places significant pressures on regulatory authorities (RAs) tasked with the review and authorisation of these drug products. In addition, companies have to grapple with different regulatory requirements and procedures among regulators. This has resulted in companies having to perform multiple sets of bioequivalence studies to support a single product in multiple jurisdictions, resulting in inefficiencies and unnecessary delays and costs to patients. Given these challenges, the benefits of regulatory cooperation, convergence and information sharing have long been recognised.
The Biowaivers Working Group was formed in May 2013 within the International Generic Drug Regulators Pilot (IGDRP) to establish a framework and mechanisms for enhanced information sharing for biowaivers. In 2016, the group expanded its scope to bioequivalence and was renamed the Bioequivalence Working Group (BEWG) to reflect this development and the collaborations that are undertaken. The group now continues as the BEWGG under the IPRP.
The work of the BEWGG has resulted in greater collaboration and regulatory convergence since its inception. This is achieved through information-sharing related to the implementation of existing regulatory guidelines and sharing of best practices, as well as a collective awareness of ongoing international developments and initiatives. In the longer term, these activities are expected to increase the efficiency of the generic drug review process while reducing regulatory burden for RAs and the generics industry.
Scope
The scope of the BEWGG covers the application and interpretation of bioequivalence requirements as well as information and procedures for the assessment of bioequivalence.
Objectives
The BEWGG identifies opportunities for regulatory convergence and harmonisation by surveying and collating information from each member agency/organisation regarding issues of common interest related to the bioequivalence assessment of generic drug products. Where appropriate, the BEWGG also develops tools to aid in the assessment of bioequivalence in generic drug products applications.
Priority Work Areas
The BEWGG’s workplan includes the following projects:
- BCS-based biowaivers
- Acceptance of foreign comparator products in bioequivalence studies
- Additional strength biowaivers (immediate- and modified-release solid oral dosage forms)
- Biowaivers for various dosage forms
- Alternative comparator product policies
- Bioequivalence study designs