European generics group welcomes WHA resolution on biotherapeutics products

The European Generic Medicines Association (EGA) has welcomed the 67th World Health Assembly’s Resolution on Access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy and the Resolution on Regulatory system strengthening for medical products.

EGA director general Adrian van den Hove commented: “These resolutions constitute important milestones for patients worldwide as they aim to support national drug regulatory authorities, particularly in developing countries, to strengthen their regulatory systems, while promoting equitable access to quality, safe, efficacious, and affordable medical products.”

Suzette Kox, director of the European Biosimilars EGA Sector Group, added that, “despite the many national and international efforts and initiatives to strengthen worldwide regulatory capacity and to move towards international convergence of regulatory practices, increased capacity building will be needed in developing countries for regulating biotherapeutic products, including similar biotherapeutics.”