Topic Editors

Departamento de Ingeniería Química y Tecnología Farmacéutica, Facultad de Farmacia, Universidad de La Laguna, 38001 Tenerife, Spain
Prof. Dr. Shein-Chung Chow
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA
Dr. Joao Goncalves
Research Institute for Medicines (iMed.ULisboa), Faculdade de Farmácia, Universidade de Lisboa, Avenida Professor Gama Pinto, 1649-003 Lisboa, Portugal

Biosimilars and Interchangeability

Abstract submission deadline
31 October 2024
Manuscript submission deadline
31 December 2024
Viewed by
342

Topic Information

Dear Colleagues,

Biological products include medications for treating many serious illnesses and chronic health conditions. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the Food and Drug Administration (FDA) or the European Medicines Agency (EMA), which is also termed the reference product. All biological products are only approved after meeting both agencies’ rigorous approval standards. This definition is based on a comprehensive review of scientific evidence, which demonstrated that the biosimilar is highly similar to the reference product and that there are no clinically meaningful differences between the two products in terms of safety, purity, and potency (i.e., safety and efficacy). This evidence included comparisons of the products at an analytical level, using a comprehensive battery of chemical and biological tests and biological assays to confirm the similarities in the structural and functional characteristics of the two products (including those known to influence safety and efficacy).Additionally, it was supported by comparative data concerning human pharmacokinetics, clinical immunogenicity, safety, and overall effectiveness.

Nevertheless, an outstanding debate surrounds the question of whether biosimilars can be regarded as interchangeable with their reference biological products (and vice versa), or with biosimilars of the same reference product.

The EMA has not issued any official position or guidance on the interchangeability of biosimilars, as prescribing and advising physicians is the responsibility of each Member State of the European Union (EU). In Europe, a biosimilar that meets the rigorous regulatory requirements of the EU Biosimilar Approval Pathway may be considered interchangeable; however, it is at the discretion of each Member State to establish prescribing and dispensing protocols for the interchangeable use of biosimilars. In the United States, the regulatory assessment of biosimilar interchangeability differs from other approaches. The Biologics Price Competition and Innovation Act of 2009 (BPCIA) legally defines it, and biosimilars that are granted interchangeability status may be substituted for the reference biological product at the pharmacy level, subject to state laws, without the prescribing physician's intervention.

The development of biosimilar products may involve various facets, such as enhancing the recognition and evaluation of product attributes, defining acceptable differences in attributes more accurately between the reference product and the suggested biosimilar product, devising analytical methods to detect relevant disparities, and undertaking comparative analytical evaluation with advanced statistical methodologies. Additionally, exploring the use of in vitro and in silico methods to assess immunogenicity could potentially support demonstrating interchangeability between the reference product and the proposed interchangeable product. In this context, the “switching design” could be of interest.

We are pleased to invite all researchers and research teams that are interested in the field of biosimilars and interchangeability to contribute to this Topic with their manuscript(s). Full original research papers, short communications, and reviews regarding this topic are all welcome.

Dr. Alexis Oliva
Prof. Dr. Shein-Chung Chow
Dr. Joao Goncalves
Topic Editors

Keywords

  • biosimilars
  • interchangeability
  • analytical similarity
  • quality attributes
  • equivalence test
  • tiered approach
  • QR method
  • margin
  • reference product change
  • immunogenicity

Participating Journals

Journal Name Impact Factor CiteScore Launched Year First Decision (median) APC
Biologics
biologics
- - 2021 27.7 Days CHF 1000 Submit
Molecules
molecules
4.6 6.7 1996 14.6 Days CHF 2700 Submit
Pharmaceuticals
pharmaceuticals
4.6 4.7 2004 14.6 Days CHF 2900 Submit
Pharmaceutics
pharmaceutics
5.4 6.9 2009 14.2 Days CHF 2900 Submit

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