Biosimilars in oncology: key role of nurses in patient education
- Biosimilars can reduce costs and improve access to cancer therapies, but unfamiliarity may hinder their adoption.
- Nurses, as trusted healthcare providers, are crucial in educating patients about biosimilars.
- Biosimilars are highly regulated and offer benefits comparable to existing biologics.
- The emergence of biosimilars follows the expiration of biologics' exclusivity agreements, potentially expanding patient access and reducing economic burdens.
- Education on the efficacy, safety, and regulation of biosimilars is vital for healthcare providers and patients.
- Nurses, due to their close interactions with patients, can significantly influence the use and acceptance of biosimilars through education.
- The review provides oncology nurses with necessary information to address patient questions about biosimilars, emphasizing the importance of understanding their production, regulation, and benefits
When patients are introduced to biosimilars, as with any new therapy, they are likely to have questions as to what they are and why they are important. In this context, it may be useful to discuss how biologics are made and compare biosimilars with generic small-molecule medicines. Although biosimilars are not generics, they can potentially have similar economic benefits and increase patient access to effective but costly medications.
What are biosimilars? Unlike small-molecule pharmaceuticals, which are chemically synthesized, biologic medicines are produced by genetically engineered cells, such as bacteria, yeast, or mammalian cells. Because small-molecule drugs are synthesized chemically, different manufacturers can produce identical drugs, referred to as generics. Since biologics are produced by living organisms, and no living cell is the same, it is impossible to independently develop a molecule that is identical to an existing biologic. When a manufacturer develops a product to achieve the same clinical result as an existing biologic, the new biologic product is called a biosimilar. Unlike generic medicines, biosimilars are highly similar but not equivalent to their reference biologic.
Regulatory agencies such as the EMA and the US FDA have strict guidelines in place to ensure that approved biosimilars do not differ from the reference biologic in their clinical benefits and risks to patients. Biosimilars must undergo rigorous testing to ensure they fit within the EMA and FDA definitions of biosimilarity. Both agencies define biosimilarity to mean that the new product exhibits properties highly similar to the reference biologic and that any small variances do not result in differences in clinical efficacy and safety. These standards are rigorously tested in a stepwise development process, described in more detail later in this review.
