Biosimilars in Oncology
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Biologics and Biosimilars".
Deadline for manuscript submissions: 20 April 2026
Special Issue Editor
Special Issue Information
Dear Colleagues,
Biologics are essential to oncology care, and biologics are often high-cost components of oncology care. Biologics have a complex production process with a larger molecular weight compared to chemically synthesized small molecule drugs, resulting in heterogeneous molecules with a physicochemical structure that is difficult to characterize. No two biological products are identical, resulting in a complex and expensive production process. A biosimilar is defined as a biologic product that is highly similar to an already licensed reference biologic that has no clinically meaningful differences in terms of safety, purity, and potency. So, biosimilar agents are biologic products that are “highly similar” to an already approved reference biologic product and have the potential to reduce the costs of biologics, potentially opening further patient access to treatment and associated outcomes. The results in biosimilar cancer treatments are not just about direct cost savings, but also to incentivize the evaluation and/or clinical use of new treatment approaches and novel drugs. Based on this, switching treatment from a reference product to a biosimilar is supported by most available data, and post-marketing pharmacovigilance programs are warranted. Therefore, the logical consequence is the different approval of biosimilar therapeutics with comparable efficacy and safety profiles for the recommended indications of their respective reference originator biologics, to integrate biosimilars, for example, into oncology treatment. Because bioequivalence does not apply to biological agents, biosimilars require more extensive analytical data to demonstrate high similarity, resulting in longer development times and higher development costs. Another major difference between a generic drug and a biosimilar is that biosimilars and their reference products are not automatically interchangeable. In contrast, automatic generic substitution is commonly performed at the point of sale for brand versus generic drugs.
This Special Issue aims to analyze the “world” of biosimilars in oncology, with a particular emphasis on interdisciplinary research involving, but not limited to, engineering, biomedical sciences, and cell biology, as well as pharmacoeconomic considerations.
Dr. Jacopo Giuliani
Guest Editor
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Keywords
- biosimilars
- oncology
- anticancer
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