A report published by the International Generic and Biosimilar Medicines Association (IGBA) highlights the key issues that support the case for the single global development of these types of pharmaceuticals. Generic and biosimilar medicines account for between 50% and 99% of all medicines dispensed in major markets. In Europe, for example, generics account for 70% of prescription medicines, yet represent only 19% of costs. While this trend highlights a global shift towards more affordable medicines, regulatory fragmentation across major jurisdictions leads to inefficiencies that impact their development, market entry, and patient access worldwide.
The study identified 52 pharmaceutical products facing specific regulatory barriers that impede widespread access: 18 simple generics, 17 complex generics, 8 biosimilars and 9 orphan drugs. The three main regulatory barriers identified include duplicate clinical assessments, reference/comparator product requirements, and manufacturing and production challenges. While complete harmonisation is not easily achievable, the report recommends targeted alignment in the identified critical area, which should be treated as a global health priority, while maintaining robust safety and efficacy standards.