In an era when increasing demands are being made on the world’s healthcare services, generic and biosimilar medicines provide a major benefit to society by ensuring patient access to quality, safe and effective medicines while reducing the cost of pharmaceutical care.
The International Generic Pharmaceutical Alliance (IGPA) was founded in March 1997 as an international network of generic medicines associations. The name of the organization was changed in September 2015 to the International Generic and Biosimilar Medicines Association (IGBA) to reflect the evolving nature of the industry.
Our vision is to promote the widest possible access to generic and biosimilar medicines with high quality, safety and efficacy, support international harmonized pathways for the registration of those medicines, and a strong commitment by members to standards agreed by the International Council for Harmonization (ICH) and WHO accredited regulators.
IGBA Reflection Paper on waiving bridging studies for biosimilar medicines applicationsIGBA proposes a new international biosimilars framework allowing bridging studies to be waived in specific circumstances based on core scientific and regulatory principles established for current products. Read More
IGBA Position on Identification of Biological, including Biosimilar Medicines 2018 Update of Facts & FiguresIGBA Position on Identification of Biological, including Biosimilar Medicines 2018 Update of Facts & Figures. Read More
IGBA submission to HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs [RIN 0991-ZA49]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… Read More
Access, sustainability and manufacturing competitiveness highlighted at global generic, biosimilar and value added pharmaceutical conference in BudapestBudapest, 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… Read More
IGBA Joins ICH Management Committee and Welcomes the Positive Vote of the General AssemblyTokyo, 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… Read More
IGBA launches a biosimilar medicines information campaignFebruary 01 2018 - Today, the International Generic and Biosimilar medicines Association (IGBA) launched an information campaign on biosimilar medicines. The foundation of this campaign is the IGBA biosimilar medicines public slide deck. Access to well-referenced information is fundamental to improving… Read More
IGBA congratulates the Australian government for maintaining their biologics naming convention and for strengthening pharmacovigilanceJanuary 29 2018 - The International Generic and Biosimilar medicines Association (IGBA) welcomes the Australian Government's decision to maintain the existing naming convention for biological, including biosimilar, medicines, that is to continue using the Australian biological name (without a specific identifier… Read More