EGA welcomes WHA resolution on biotherapeutic products

June 6, 2014 7:17 AM

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 Hoven 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.”

To meet the target of access to high quality, safe, efficacious and affordable similar biotherapeutic products, EGA recommends the full implementation of the biosimilarity scientific principles laid down in the 2009 World Health Organization guidelines on evaluation of similar biotherapeutic products (SBPs), as well as setting up worldwide regulatory frameworks supporting the global development of biosimilars to ensure the implementation of high regulatory standards while avoiding the repetition of unnecessary and potentially unethical clinical trials.

To increase regulatory capacity in developing countries, Twinning projects involving experienced and less experienced national drug regulatory authorities (NRAs) should be promoted. Twinning projects, based on the secondment of experts from experienced to less experienced NRAs, can deliver specific and guaranteed results.

Ms. Kox presented the Twinning proposal on behalf of the EGA at the May WHO/MFDS implementation workshop on the evaluation of similar biotherapeutic products in Seoul, South Korea. The proposal is inspired by the very successful Twinning projects launched in the European Union in May 1998 to support EU accession countries in meeting the Acquis Communautaire.

“WHO could take over the role of facilitator and WHO members and capacity building donors are invited to support this proposal aiming at improving access to high quality, safe and efficacious biotherapeutic products for patients around the world,” Ms. Kox concluded.

Source: EGA press release

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