In order to enhance regulation of biotherapeutic medicines, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva is organising an international scientific and regulatory conference 'Biotherapeutic medicines: sharing experiences and best practices' today in Lima.
The conference is organised in cooperation with its Latin American national and regional member associations: ALAFARPE (Peru), AFIDRO (Colombia), AMIIF (Mexico), CAEMe (Argentina), cif (Chile), Fedefarma (Central America), FIFARMA (South America Region), IFI (Ecuador), and Interfarma (Brazil).
The conference titled “Biotherapeutic medicines: sharing experiences and best practices”, involves the participation of leading scientific, regulatory and academic experts from Argentina, Brazil, Chile, Ecuador, Mexico, and Peru. Other speakers include representatives of WHO, Health Canada, and industry.
During the symposia, experts will discuss the current challenges in regulating biotherapeutic and biosimilar medicines and exchange national and regional best practices.
Ahead of the conference, IFPMA Biotherapeutics Group Chair Fermin Ruiz de Erenchun (Roche) said, "Due to the complex nature of biotherapeutic medicines, harmonized regulatory standards are needed to best serve the interests of patients and healthcare systems throughout the region. We hope this conference will offer a constructive platform for dialogue in which national and regional health authorities and international experts will share and discuss current norms and best practices.”
Eduardo Pisani, director general, IFPMA said, "Biotherapeutic medicines open new treatment possibilities for patients and offer cures for some diseases that were previously considered untreatable. With more than 200 biotherapeutic medicines now registered and many others in the pipeline, science-based, harmonized regulatory approaches are needed to make them readily available for patients. This conference is an important platform for sharing regulatory best practices among leading experts."
Biotherapeutic medicines are larger and more complex than many chemically-synthesized small molecule medicines. Derived from living organisms, their characteristics and properties are highly dependent on the manufacturing process and conditions. These medicines have benefitted more than 350 million patients worldwide in treating both common as well as rare diseases. Because these medicines' complexity poses important new challenges for regulators, the conference focuses on technical challenges in manufacturing biotherapeutics, evaluation and registration of biotherapeutic and biosimilar products, immunogenicity and safety monitoring, interchangeability, and pharmacovigilance.