June 13 2017 - IGBA is pleased to announce today the nomination of Ingrid Schwarzenberger, Head Global Regulatory Affairs at Sandoz Biopharmaceuticals, as the new Chair of the IGBA Biosimilars Committee. Ingrid has played a leading role in the establishment of a regulatory framework for biosimilar medicines in Europe through her 15 years of experience with the Biosimilar Medicines Group, a Medicines for Europe sector group. Ingrid has a wealth of international regulatory knowledge and business and scientific experience.
March 14, 2017 - On 9th March, IFPMA launched jointly with EFPIA and EBE a position paper entitled Considerations for physicians on switching decisions regarding biosimilars. Physician-led switching of biological medicines is a well-known medical practice. Although data on the frequency of switching in clinical practice is scarce, no evidence from clinical trials or post marketing surveillance data has found that switching to or from different biotherapeutics leads to safety concerns.
- IGBA Statement on the Final Report of the United Nations Secretary General’s High Level Panel on Access to Medicines
- IGBA Joins ICH and Welcomes the Positive Vote of the General Assembly
- Generic, Biosimilar and Value Added Medicines Industry Leaders Join Forces to Drive Access to Medicines Agenda
- IGBA commentary on FDA’s Draft Guidance on Labeling for Biosimilar Products