Biosimilars in Oncology: Applications in Pharmaceutics and Pharmaceuticals

Dear Colleagues,

The development of biosimilar cancer treatments does not just offer direct cost savings, but also incentivises the evaluation and/or clinical use of new treatment approaches and novel drugs, as switching from a reference product to a biosimilar treatment is supported by most available data. Post-marketing pharmacovigilance programmes are therefore warranted. As such, in order to integrate biosimilars, for example, into oncology treatment, the logical consequence is to provide differing approval for biosimilar therapeutics with comparable efficacy and safety profiles for the recommended indications of their reference originator biologics. Because bioequivalence is not applicable to biological agents, compared with generics, biosimilars require more extensive analytical data to demonstrate their high similarity, which results in a longer development time and higher development costs for biosimilars.

Reference studies for the approval of biosimilar drugs typically consist of two parts: the primary objective is to show the equivalence of a biosimilar and reference drug in the pharmacokinetic subset (part 1) and their overall response (noninferior efficacy in the efficacy population) (part 2) during the combination phase. The result is their translation into clinical practice in single randomized controlled trials with different settings (neoadjuvant, adjuvant, and metastatic) based on reproducible efficacy data.

The aim of this Special Issue is to analyze the “world” of biosimilars in oncology with a particular focus on interdisciplinary research involving, but not limited to, biosimilars, oncology, pharmaceutical formulations, drug delivery, pharmacokinetics, biopharmaceutics, engineering, biomedical sciences, and cell biology, and also with a reference to pharmacoeconomic considerations.

Pharmaceutics invites submissions related to pharmaceutical formulation, process development, drug delivery, pharmacokinetics, and biopharmaceutics, while Pharmaceuticals encourages contributions centered on drug discovery and development, Medicinal Chemistry, and pharmacology.

You may choose our Joint Special Issue in Pharmaceuticals.

Dr. Jacopo Giuliani
Guest Editor