Formulation and Quality – Chemical
2019 PharmSci 360
What is the current state of the debate on Non-biological Complex Drug products (NBCDs)? This presentation will reflect on ongoing discussions around the challenges in demonstrating therapeutic equivalence of complex drug products, including nanosimilars and complex generics. Case studies will highlight the different approaches taken around the world by developers and regulatory authorities. After indicating outstanding issues, this presentation will conclude with recommendations for advancing the science based discussions on an international level.