The World Health Organization (WHO) has announced a pilot project that will take advantage of expected savings from biosimilar medications, particularly expensive anticancer agents, to make these treatments available for low- and middle-income countries.
The agency plans to focus on 2 anticancer drugs, rituximab and trastuzumab, which are included in the WHO Essential Medicines List.
This list includes medicines that “satisfy the priority care needs of the population,” and candidate medications are selected based on disease prevalence and evidence of safety, efficacy, and drug cost as well as cost effectiveness.
For the pilot project, WHO will invite manufacturers of biosimilar products to submit applications for prequalification of their biosimilar versions of rituximab and trastuzumab.
Rituximab is primarily indicated for non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, while trastuzumab is indicated for breast cancer. There might also be a similar project for prequalifying insulin. Prequalification by WHO can also increase market competition and further reduce drug price.
WHO invited national regulators, pharmaceutical industry groups, patient and civil society groups, payers, and policymakers to participate in a 2-day meeting in Geneva to address ways to increase access to costly biologic medications. “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,” said Marie-Paule Kieny, MD, WHO assistant director general for health systems and innovation.
Biosimilars submitted for prequalification, if found comparable to the reference product with respect to quality, safety, and efficacy, will be listed by WHO, thereby making them eligible for procurement by the United Nations agencies. With regard for safety and efficacy for biosimilar products, WHO will evaluate countries that have had a positive experience with biosimilars and it plans to educate both patients and providers on the benefit of these medicines.
With respect to the economics of biosimilars, WHO plans to lend support to countries to develop price-setting strategies that can save money for patients and payers, while maintaining incentives for manufacturers.
A biosimilar to trastuzumab, manufactured by Biocon and Mylan, recently received marketing approval in India for additional indications of early-stage breast cancer and gastric cancer. The product is currently under review with both the FDA and the European Medicines Agency. Additionally, the South Korean company Celltrion has announced US regulatory filings for its biosimilar versions of both trastuzumab and rituximab.
Biosimilars
