BCS-Based Biowaivers: Streamlining Bioequivalence Assessment Through in Vitro Approaches

The Biopharmaceutics Classification System (BCS) enables the scientific and regulatory framework for granting biowaivers of in vivo bioequivalence studies. By categorizing drug substances according to solubility and permeability, the BCS allows the substitution of traditional clinical trials with validated in vitro testing. Recent regulatory guidance, including ICH M9 and EMA’s reflection paper (CHMP/QWP/708282/2018), outlines the requirements and limitations of this approach, fostering both efficiency and patient-centric development. BCS-based biowaivers significantly reduce the ethical and financial burden of unnecessary human studies, while maintaining rigorous quality and safety standards. This presentation will highlight the principles of BCS classification, testing strategies, and the regulatory criteria for eligibility. Case examples will demonstrate how in vitro data support formulation optimization, lifecycle management, and global regulatory submissions. Ultimately, the BCS framework offers a science-driven, harmonized path to accelerate market access and ensure consistent product performance.