WHO and IGBA Sign Agreement to Promote Biosimilars and Generics

The World Health Organization (WHO) and the International Generic and Biosimilar Medicines Association (IGBA), an umbrella organization with members including the Association for Accessible Medicines, Medicines for Europe, and a number of other national and regional generic and biosimilar organizations, have signed a memorandum of understanding.

The agreement highlights the role that the pharmaceutical industry has in helping the WHO maintain tools to facilitate the approval of generics and biosimilars. According to a statement by the WHO, the memorandum will help facilitate cooperation between drug makers and the WHO to reduce the burden of clinical trials for biosimilars, and it will help speed registration and patient access to these drugs.

Among the WHO’s ongoing efforts to increase access to biosimilars is its List of International Comparators, which provides information on reference products that can be used in clinical trials, and its prequalification program, which assesses the quality, safety, and efficacy of medicinal products.

Prequalification ensures that medicines supplied by international procurement agencies meet acceptable standards of quality, safety, and efficacy, and gives the procurement agencies working to distribute drugs in resource-limited countries the choice of a wide range of quality medicines for bulk purchase. Prequalification activities for biosimilars began in 2017.

Earlier this year, speaking at the Medicines for Europe 18th Regulatory and Scientific Affairs Conference, Deus Mubangizi, DrPh, group lead of inspection services on the WHO’s prequalification team, underscored the importance of prequalification activities, and also highlighted ways in which industry and the WHO can partner to facilitate access to medicines.

Mubangizi said there exists a need to reduce the number of repetitive studies conducted for biosimilars, which he said may not always be science-based and may even border on being unethical.

“We approach this issue from the concept that safe, efficacious, good-quality, and affordable medicines should be available for everyone, not just a few,” he said, and explained that eventually using a global reference product in biosimilar development, which could facilitate global approval, is one key way to promote access.