Brussels, June 3, 2016 – IGBA thanks the Agency’s for providing an opportunity to comment on the Agency’s Draft Guidance on Labeling for Biosimilar Products (Docket No. FDA-2016-D-0643-0001). IGBA’s position is aligned with the key comments of the Biosimilar Medicines Group, a sector group of Medicines for Europe, which have been submitted separately.
Friday May 27, 2016 – The International Generic and Biosimilar Medicines Association (IGBA) represents companies that are actively engaged in the global manufacturing and trading systems for medicines. Our membership includes the EGA (Europe), the CGPA (Canada), the GPhA (USA), the JAPM (Jordan), the NAPM (South Africa), the TGPA (Taiwan) and the JGA (Japan). Associations from Australia (GBMA), Brazil (ProGenericos), Mexico (AMEGI) and Malaysia (MOPI) are Associate Members.
The International Generic and Biosimilar medicines Association (IGBA) welcomes the WHO’s continuous interest in the development of a global identification system for biological substances, as well as the decision to perform an impact study assessment of the voluntary Biological Qualifier (BQ) proposal. However, IGBA does not support the BQ proposal since successful product identification and tracking using multiple identification components are already in force, such as the brand name or the INN combined with the company name, the lot number and various national codes.
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