The horizon appears brighter for cancer patients in low and middle-income countries such as Nigeria as the World Health Organization launches a pilot scheme that hopes to make some of the most expensive treatments for the disease more widely available in these countries.
According to a press statement, the global health agency in September will invite manufacturers to submit applications for prequalification of biosimilar versions of two products in the WHO Essential Medicines List: rituximab (used principally to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia), and trastuzumab (used to treat breast cancer).
Biotherapeutics are pharmaceutical products derived from biological and living sources and are important treatments for some cancers and other non-communicable diseases. They include therapeutic vaccines, blood, blood components, cells, gene therapies, tissues and other materials.
Several biologic medicines are ‘specialty drugs’, highly priced and effective in treating medical conditions for which no other treatments are available. Gene- and cell-based therapies are among these pharmaceuticals. And some biotherapeutics are effective treatments for certain forms of cancer, chronic diseases such as diabetes, Crohn’s disease and other autoimmune conditions, including lupus and various forms of rheumatoid arthritis.
The decision to invest in the less expensive treatment option was made after a two-day meeting in Geneva between WHO, national regulators, pharmaceutical industry groups, patient and civil society groups, payers and policymakers to discuss ways to increase access to biotherapeutic medicines.
WHO also plans to explore options for prequalifying insulin.
Marie-Paule Kieny, WHO Assistant Director General for Health Systems and Innovation, said innovator biotherapeutic products are often too expensive for many countries, so biosimilars are a good opportunity to expand access and support to countries to regulate and use these medicines.
“Like generic medicines, biosimilars can be much less expensive versions of innovator biotherapeutics. They are usually manufactured by other companies once the patent on the original product has expired.
“As the patents of some biotherapeutics have expired, more biosimilars are being produced. Like generic medicines, biosimilars could help to increase access to treatment in lower-resourced countries and provide a solution to escalating health costs in high-income countries”, she added.
Currently, cancer treatment in Nigeria has suffered a setback as many cancer machines in the country are not working, so patients either travel abroad for treatment or make do with what is available at high prices.
Debo Omikunle, an oncologist, said treatment in Nigeria has not recorded much success because of late presentation by patients and the lack of equipment for diagnosis and treatment.
“The success rate of treatment has been low because we don’t have enough equipment and machinery for treatment,” he said.
According to the statement, if WHO finds that the biosimilars submitted for prequalification are comparable to originator products in terms of quality, safety and efficacy, the medicines will be listed by WHO and become eligible for procurement by United Nations agencies.
“Many low- and middle-income countries also rely on WHO prequalification before buying medicines. An additional benefit of WHO prequalification could be to increase competition and further reduce the price of medicines.
“WHO will also review its 2009 Guidelines on the evaluation of similar biotherapeutic products to ensure that WHO’s guidance to national regulatory authorities reflects recent evidence and experience”, it stated.
Suzanne Hill, 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 regulated appropriately to ensure therapeutic value and patient safety.
She added that increased use of biosimilars will also require patients and their physicians to understand and trust that the benefits of this type of medicine substantially outweigh any risks.
WHO will be looking to countries with positive experience of biosimilars and partners for support in educating prescribers and patients on the benefits of these medicines and in advocating for greater awareness of biosimilars.
According to the global health agency, appropriate regulation of biosimilars is also of paramount importance for the quality, safety and efficacy of the treatment.
The agency explained that as their source is biological, or living, the product may change during manufacture and no biotherapeutic product of the same category is exactly the same as another. It is therefore more difficult to make a comparison between a biosimilar and its original, than it is between chemically identical active ingredients in a fully synthesised medicine.
“For that reason, WHO must accompany global policies on expanding access to biosimilars with rigorous guidance on the way these medicines are quality-assured before they enter markets”, it stated.
In addition, WHO will advocate fairer prices for all biotherapeutics to ensure that these treatments can truly benefit public health.
This will include support to countries to develop price-setting strategies that foster sustainable markets to deliver treatments to patients, savings to payers and incentives to producers to keep manufacturing the medicines needed.
Every year, billions of dollars’ worth of medicines and other health products are purchased by international procurement agencies for distribution in low-income countries. Prequalification is a service provided by WHO to assess the quality, safety and efficacy of those products that address global public health priorities.
If the products meet international standards, they are listed on the WHO website as eligible for procurement, giving purchasing agencies a range of quality-assured diagnostics, medicines and vaccines from which to choose. Many low-income countries also use WHO’s lists of prequalified products to guide their selection of medicines, vaccines and technologies for national procurement.