The latest Review published in Future Oncology discusses the development and approval process of biosimilar medicines such as SB3. The robust mechanisms put in place by regulatory bodies for approving biosimilar drugs are described, which are based on comprehensive, rigorous analytical comparisons with the originator, allied to an abridged non-clinical and clinical development program.
Biosimilars are biologic products that are highly similar to, and have no clinically meaningful differences from, the approved originator molecule. They are poised to play an increasingly central role in cancer treatment, helping to improve access by driving down costs. Regulatory bodies have set out robust mechanisms for the approval of biosimilars, based on comprehensive and rigorous analytical and non-clinical comparisons with the originator. Product attributes (e.g. post-translational modifications) that are important to the function of the molecule must be similar between biosimilar and originator. This should be followed by a robust clinical development program, assessing pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity. Equivalence in one indication might allow extrapolation across all the indications of the originator biologic. The recent approval of several trastuzumab biosimilars provides an example of how this process can work in practice for the benefit of patients, clinicians and payers.