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The ESMO position paper on biosimilars in oncology: enhancing the provision of accurate education and information

The recent ESMO position paper on biosimilars in oncology1 was timely, given the rapidly increasing range of biologic medicines and the potential to develop biosimilar medicines in this area. As the position paper clearly states, biosimilar medicines can positively impact the financial sustainability of healthcare systems around the world.1 The paper also correctly highlights the importance of providing accurate information to all stakeholders involved. This is essential in order to avoid misunderstanding and misconceptions about biosimilar medicines.

Biologic medicines, whether reference biologics or biosimilars, are recognised as being much more complex than traditional, chemically-synthesised drugs. A biosimilar, as defined by the EMA, is a biologic medicine that is similar to another biologic medicine that has already been authorised for use.2 A science-based regulatory framework has been established in the European Union (EU) since 2005 to ensure the development and approval of high-quality biosimilars; this framework is regularly reviewed and updated.3–5 The requirements for biosimilar development and approval are based on those that are in place for any biologic medicine; the manufacturer is required to demonstrate similarity to the reference medicine in terms of safety, efficacy and quality. This contrasts with the requirements for approval of generic versions of chemically synthesised, small-molecule drugs, which typically only require demonstration of identical structure and pharmacological …