Abstract
The World Health Assembly in 2014 adopted a resolution that recognized the importance of increasing access to biotherapeutic products, of improving their affordability and of ensuring their quality, safety and efficacy. Biosimilars are biotherapeutic products similar to already licensed reference products and are usually developed after patents on the original products have expired. Their introduction into the market is likely to reduce the costs of medicines substantially, thereby improving the availability of treatment for patients. However, there are barriers to market access for biosimilars. This article discusses the factors that give rise to these barriers and explains the importance of regulatory oversight throughout the product life-cycle of biosimilars. The paper also describes the role regulators can play in increasing confidence in biosimilars use by: (i) establishing regulatory oversight of biosimilars throughout their life-cycle, from development to post-licensing oversight, and ensuring that only high-quality, safe and efficacious biosimilars are available on the market; (ii) ensuring regulatory authorities have adequate capacity to assess and monitor the quality, safety and efficacy of biosimilars throughout their life-cycle; and (iii) monitoring the use of biosimilars in public health systems in collaboration with other stakeholders.
Highlights
Countries around the world face the common problems of an aging population and the associated increase in the prevalence of chronic diseases
The success of biotherapeutic products, such as such as large complex proteins, for treating human diseases, in the treatment of many life-threatening chronic conditions, combined with the approaching expiry of patent protection on these products, has led to increased interest in the development of biosimilars, which are products that are similar to the originals
European Union countries have the longest history of using biosimilars and it is expected that, as a result, these countries’ health-care systems could save 11.8 to 33.4 billion euros between 2007 and 2020.2 A recent report concluded that competition from biosimilars has led to a consistent reduction in the average price of treatment in clinical areas where they have been introduced and that, in some countries, patients began to have access to product classes that were previously unavailable.[3]
Summary
Countries around the world face the common problems of an aging population and the associated increase in the prevalence of chronic diseases. Some countries have biotherapeutics on their markets that are claimed to be copies of original products (i.e. so-called non-innovator or copy-version products) These medicines have not been approved through a biosimilar approval procedure but have, instead, been licensed as generics or small-molecule medicines.[9] as biotherapeutics are relatively large and complex proteins, procedures established for generics or small-molecule medicines are not suitable for the development, evaluation or licensing of biosimilars.[4] As stated in WHO’s guidelines on the evaluation of similar biotherapeutic products, a biosimilar that has not been demonstrated to be similar to a reference product through head-to-head comparisons should not be described as similar or be called a biosimilar.[4] These guidelines stipulate that, “regular review of NRAs [national regulatory authorities] for their licensing, for adequacy of their regulations for providing oversight, and for the processes and policies that constitute the regulatory framework is an essential component of a well-functioning and up-to-date regulatory oversight for biotherapeutics”.4. This step-wise approach to regulatory assessment is recommended by WHO and is intended to be flexible and to increase access to biotherapeutic products, including biosimilars of assured quality, safety and efficacy.[9]
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