WHO to Start Pilot Prequalification of Biosimilars for 2 Cancer Treatments

The World Health Organization (WHO) announced that it will launch a pilot project later in 2017 for prequalifying biosimilars of cancer medications. The organization noted that it was a step towards making some of the most expensive biotherapeutic cancer treatments more accessible to low- and middle-income countries.

The Prequalification of Medicines Programme (PQP) is a service provided by WHO to assess 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. If the drugs meet international standards, they are listed on the WHO website as eligible for procurement, giving purchasing agencies a range of quality-assured medicines, vaccines, and diagnostics from which to choose. Many low-income countries use WHO’s list of prequalified products to guide their selection of medicines, vaccines, and technologies for national procurement, according to WHO, and it may also contribute to an increase in competition and further reduce the price of medicines.

In September 2017, WHO will invite manufacturers to submit applications for prequalification of biosimilar versions of 2 products on the WHO Essential Medicines List: rituximab (Genentech’s Rituxan, used principally to treat Non-Hodgkin’s lymphoma and chronic lymphocytic leukemia) and trastuzumab (Roche’s Herceptin, used to treat breast cancer and stomach cancers). WHO is also studying options to prequalify insulin.

Once PQP invites manufacturers, they are asked to provide a comprehensive set of data about the quality, safety, and efficacy of the product being evaluated, including purity, stability, and clinical trial data. A team of assessors, including WHO staff and experts from global regulatory authorities, evaluates the presented data. Inspectors verify that manufacturing sites comply with WHO good manufacturing practices and verify that at any contract research organization that conducted trials related to the product also comply with WHO good clinical and laboratory practices. The PQP process can take from 3 months onward depending upon the quality of the data and completeness of the manufacturer’s records.

“Innovator biotherapeutic products are often too expensive for many countries, so biosimilars are a good opportunity to expand access and support countries to regulate and use these medicines,” noted Marie-Paule Kieny, MD, WHO assistant director general for health systems and innovation. If WHO finds that the biosimilars submitted for prequalification are comparable to the originator products in terms of quality, safety, and efficacy, the organization will list those medicines, which will become eligible for procurement by United Nations agencies.

Suzanne Hill, B. Med (Hons), Grad Dip Epi, PhD, FAFPHM, WHO’s director of essential medicines and health products, said biosimilars could be game-changers for access to medicines for certain complex conditions, but they need to be appropriately regulated to ensure therapeutic value and patient safety. She noted that increased use of biosimilars will require patients and prescribers to understand and trust that the benefits of biosimilars substantially outweigh any risk. WHO will be looking to countries with positive experiences with biosimilars, and partner for support in educating prescribers and patients on their benefits.