The mandate to conduct routine comparative clinical efficacy studies for biosimilar medicines, compounded by duplicative regional requirements, serves as a barrier to greater medicine access for patients. The International Generic and Biosimilar Medicines Association (IGBA) has issued two position papers; the first proposing streamlined development through reduced clinical studies and the second proposing use of the same comparator product across jurisdictions. 

Pharmaceutical innovation drives progress, and deserves reward, with intellectual property playing a key role in its protection. Expanding access to these innovations after rewarding them is crucial for public health. In well-functioning markets, generic and biosimilar medicines provide affordable, quality-assured therapeutic options enabling widespread access without compromising safety, efficacy, or quality. This balance supports Universal Health Coverage, reduces financial vulnerability, and ensures sustainable healthcare systems, contributing to Sustainable Development Goals 1, 3, and 10.

The International Generic and Biosimilar Medicines Association (IGBA) commends the General Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its decision to develop  an Addendum to the ICH M7 Guideline on Assessment and Control of DNA Reactive (mutagenic) impurities, to incorporate the latest scientific advancements supporting the safety assessment and control of nitrosamine impurities into internationally harmonized guidance.