HPE HPE Fresenius Kabi handbook - Page 24

BENEFITS Benefits of biosimilars Prescribers, as well as other health professionals, payers, and patients, should be aware of the potential advantages and disadvantages of biosimilars in order to allow for an optimal treatment plan, and one that is adapted to the patients’ particular conditions, needs, and preferences Mike Scott PhD Medicines Optimisation Innovation Centre, Antrim, Northern Ireland, UK Despite some uncertainty surrounding the bioavailability, onset of action, duration of action, and adverse events of biosimilars, their development and subsequent regulatory approval these past years have been received with great expectation, given the potential substantial gains their use brings to health systems in general and patients in particular. Although there has been a rapid increase in the number of biosimilars available worldwide recently, mainly in the fields of oncology and rheumatology, their uptake has been comparatively slow, which is in part due to lack of knowledge of their benefits by the different elements in the process of treatment decision making. 1,2 Clinicians Currently, the US Food and Drug Administration 24 | 2019 | hospitalpharmacyeurope.com only requires proof of similarity to the reference product in terms of structure and function, with no significant differences in purity, safety and efficacy. In the EU, the functional and structural characteristics must be similar between the reference biologic product and follow-on biosimilar, and the pharmacokinetic, efficacy, safety and immunogenicity data must be consistent for both molecules. 2,3 Other countries might have less stringent requirements for approval of a biosimilar, and the subsequent post-marketing monitoring and surveillance needs might differ as well. However, given the unavailability of precise methodologies to determine the structure of large biological molecules, the standards applied to evaluate the original molecules may not be appropriate to evaluate the biosimilar copies. 1 These limitations can have a significant influence