WHO Launches Pilot Prequalification for Human Insulin

November 14, 2019
The Center for Biosimilars Staff

The World Health Organization (WHO) this week announced its pilot procedure for the prequalification of human insulin as means to facilitate access to safe, effective, and quality-assured insulin and insulin biosimilars for type 1 and type 2 diabetes in low- and middle-income countries.

The World Health Organization (WHO) this week announced its pilot procedure for the prequalification of human insulin as means to facilitate access to safe, effective, and quality-assured insulin and insulin biosimilars for type 1 and type 2 diabetes (T2D) in low- and middle-income countries.

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

If drugs meet international standards, they are listed on the WHO website as eligible for procurement, giving purchasing agencies a range of products from which to choose. Many low-income countries use WHO’s list of prequalified products to guide their selection of medicines, and prequalification may also contribute to an increase in competition that reduces costs for these medicines.

Drug makers who wish to express their interests in having their products evaluated in this program are invited to submit their information to the WHO prequalification team for biotherapeutic products. The WHO will then perform inspections to determine whether products are manufactured in keeping with good manufacturing practice.

“Diabetes is on the rise globally, and rising faster in low-income countries,” said Tedros Adhanom Ghebreyesus, MSc, PhD, WHO’s director general, in a statement. “Too many people who need insulin encounter financial hardship in accessing it, or go without it and risk their lives. WHO’s prequalification initiative for insulin is a vital step towards ensuring everyone who needs this life-saving product can access it.”

WHO data from 24 countries show that, between 2016 and 2019, human insulin was available in only 61% of health facilities, and analogue insulins were available in only 13% of health facilities. High costs compound access problems for patients with diabetes in low-resource countries, and even in wealthy nations, individuals sometimes ration insulin because of cost. Worldwide, estimates the WHO, only half of patients with T2D are able to access insulin.

Other steps the WHO is taking to improve care for diabetes worldwide include updating diabetes treatment guidelines, creating drug price reduction strategies for analogue insulins, and improving delivery systems and access to diagnostics.