16th July 2018. In its submission, IGBA invites the FDA to waive the requirement for bridging studies when a foreign-licensed reference comparator product is used for biosimilar development,  given that the locally licensed reference product and the foreign-licensed product are versions of the same product. This constitutes an important and effective development tool in reducing the development costs for biosimilars and interchangeable products, will increase competition and hence will improve access to these life-saving innovative treatments.

Budapest, 14th June 2018. Industry leaders from the generic, biosimilar and value added medicines industries discuss challenges and opportunities in ensuring sustainable, worldwide patient access to pharmaceuticals. Medicines for Europe and the International Generic and Biosimilar Medicines Association (IGBA) join forces to tackle challenges such as market sustainability, medicines shortages, and international regulatory cooperation. Opportunities can be pursued with strong stakeholder collaboration for a sustainable industry. These include the introduction of an EU SPC manufacturing waiver, and ensuring that generic, biosimilar and value added medicines can play their role in providing better access for better health.   

Tokyo, Japan (June 7, 2018) The International Generic and Biosimilar Medicines Association (IGBA) very much welcomes today’s decision of the ICH General Assembly to elect the IGBA as an Management Committee Member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use  (ICH).