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Pilot Procedure for Prequalification of Human Insulin

In recent years, a great number of biotherapeutic products (BTPs) have demonstrated success in treating many life-threatening chronic diseases. In May 2014, the World Health Assembly (WHA) adopted Resolution WHA67.21 on “Access to biotherapeutic products, including similar biotherapeutic products, and ensuring their quality, safety and efficacy”.

BTPs are highly complex biological medicines and the regulatory assessment of those products according to internationally acceptable guidelines and standards can be challenging in some countries. In order to explore options to facilitate access to safe, effective and quality assured BTPs, WHO is launching a pilot project to prequalify BTPs containing the active ingredient human insulin.

Insulin was discovered as a treatment for diabetes almost 100 years ago and has been on WHO’s Essential Medicines List since the first List was published in 1977. In spite of this, current insulin prices and availability pose a barrier to treatment in most low- and middle-income countries. In wealthy countries, there are several examples of people that cannot reliably access this life-saving medication because it is unavailable, unaffordable or both.

WHO’s RHT is therefore exploring options to facilitate access to human insulin at affordable prices by developing a WHO pilot procedure for prequalification of human insulin and is inviting manufacturers to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Team – Biotherapeutic Products (BTPs).

This invitation is limited to:

• Human insulins that have been registered by non-SRAs and marketed in a specific country; and which will be assessed via a Full Assessment pathway.
• Human insulins that have been approved by stringent regulatory authorities (SRA); and which will be assessed via an Abridged Assessment pathway.

In case the product is claimed to be an SBP (based on a Reference biotherapeutic product, RBP approved by an SRA), data demonstrating similarity of the SBP to a suitable RBP in terms of quality characteristics, biological activity, safety and efficacy will be required.