Presentation (CTI)

OBJECTIVES: There is considerable potential for improving healthcare cost-effectiveness via complex generic drugs; nevertheless, developing and approving these drugs remains very difficult. The purpose of this study is to critically evaluate the important challenges in developing and regulating complex generics throughout the product lifecycle.
METHODS: A mixed methods research design was adopted. A systematic scoping review was carried out on the basis of PRISMA-ScR recommendations, mapping the current evidence on developmental and regulatory issues. Furthermore, thematic in-depth interviews were conducted with expert industry executives and regulators (≥5 years of experience).
RESULTS: The results of this study revealed a range of complex issues, including (i) the absence of harmonized regulatory guidance on complex generics, (ii) high demands on analytical characterization and bioequivalence studies, (iii) insufficient access to advanced analytical methodologies, (iv) inconsistent regulatory landscapes among global bodies, and (v) large financial risks and resource limitations in the industry. Inconsistency between regulatory standards was seen as a major barrier, causing prolonged approvals and restricted market penetration. The significant facilitators were the early engagement of regulators, the use of sophisticated analysis tools, development strategies for global products, and improvements in regulatory sciences infrastructure.
CONCLUSIONS: This study provides comprehensive empirical evidence on the most critical obstacles involved in the developmental and regulatory processes of complex generics. These barriers could be addressed to expedite the development process, leading to the rapid availability of cost-effective medicines. The results generated in this study can be used by decision makers, industry experts, and international public health organizations to shape the regulatory environment for complex generics.