IGBA, the International Generic and Biosimilar medicines Association, representing global manufacturers of generic and biosimilar medicines, announced today that AMIP has been accepted and welcomed as a new IGBA Associate Member.
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.
