Читать книгу Biologics, Biosimilars, and Biobetters - Группа авторов - Страница 19

Biobetters are related to existing biologics by the target of action but have been intentionally improved in manufacturing attributes, disposition/pharmacokinetics, efficacy, safety, or enhanced stability.³¹ Biobetters build on the success of an approved innovator biologic or biosimilar but possess a lower commercial risk for biotechnology companies than a novel class of biologic. Biobetters are also known as second‐generation biologics.

Biobetters improve on the relevant property of biologics. Many innovator biologics or biosimilars have less than optimal pharmacokinetic properties (e.g. high clearances or short half‐lives). Besides, almost all these proteins are dosed parenterally by injection rather than orally. Thus, modifications to improve their pharmacokinetic behavior have led to biobetters. Examples include pegylated longer half‐life version of filgrastim or a more extended half‐life version of epoetin α, using fusion proteins.

While biosimilars are comparable to the originator product in terms of quality, safety, and efficacy, biobetters incorporate intentional modifications to the innovator's molecular profile. This distinction between biosimilars and biobetters has essential implications from a regulatory perspective. Biosimilars follow class‐specific regulatory guidance whereas biobetters are considered as new molecular entities and have registration requirements of a new drug.

Biobetters may have advantages due to their pharmacologic comparability to innovator biologics, which may accelerate their development. For instance, choice of their dose and biomarkers in both nonclinical and clinical studies is simpler, and prior knowledge from the innovator biologic may reduce the scale/duration of clinical trials and safety monitoring focused on known side effects of the target pathway.