Ethical and regulatory issues related to biosimilar medicines

Abstract

Biosimilar medicines are considered by governments as a solution to increase accessibility to very expensive biological medicines. This dissertation attempts to identify the ethical and regulatory issues related to biosimilar medicines through an in-depth literature review. The first chapter involves literature related to biological medicines and intellectual property regulations in Europe. The second chapter covers the literature on regulation of biosimilar medicines in Europe. In the third chapter, the literature covers an analysis on the expenditure of biologicals and their economic burden, the different models of switching and substitution, their implementation within the public health care system, and the success of biosimilar uptake strategies. Chapter 4 focuses on the literature on the emerging ethical issues. It is concluded that a ‘knowledge gap’ of the cell line and the manufacturing process of originator biological medicines hinders other manufacturing companies from producing copies. The extensive intellectual property protection regulations in Europe contribute to the low number of biosimilars authorised in Europe and their delay from reaching the market. The European Medicines Agency (EMA) was at the forefront to set up a regulatory framework for biosimilars, which however are not therapeutically equivalent and therefore not interchangeable. The EMA leaves the decision of interchangeability to Member States. The safety concerns on switching to biosimilars are pronounced. Governments set different policies to improve the uptake including mandatory switching, but there is no coherent policy framework which could lead to inequality whilst the uptake of biosimilars remains low. Globalisation of the pharmaceutical industry led to the need for harmonisation and convergence of regulations which is the 21st century best regulatory practice. From the ethical perspective, good governance is required to ensure impartiality in decision taking at all levels to improve access to biosimilars and ensure fair competition. Safety is the main ethical issue related to biosimilars, where safe regulation is recommended through physician-led prescribing. Mandatory switching presents further ethical concerns. A holistic policy framework is required by governments which should be based on the principles of justice, solidarity, precaution and integrity so as to ensure equitable access to medicines on a national, European and global level. Biosimilars may be part of the solution through harmonised regulation and public health care systems that are built on the principle of solidarity.