Biosimilarity and Interchangeability

As more biological products are going off patent protection, the development of follow-on biologics (biosimilars) has received much attention from both the biotechnology industry and the regulatory agencies since the United States (US) Congress passed the Biologics Price Competition and Innovation (BPCI) Act (as part of the Affordable Care Act) on 23 March 2010. In order to obtain input on specific issues and challenges associated with the implementation of the BPCI Act, the US Food and Drug Administration (FDA) conducted a two-day public hearing on Approval Pathway for Biosimilar and Interchangeability Biological Products held on 2–3 November 2010, and a follow-up one-day public hearing on Draft Guidelines relating to the Development of Biosimilar Products held on 11 May 2012. Several scientific factors regarding test for biosimilarity, interchangeability, and comparability in manufacturing process were identified. These scientific factors, however, remain unsolved pending on regulatory guidance which is expected to be circulated for comments/input by the end of 2012.

Unlike traditional small-molecule (chemical) drug products, the development of biological products is very different and variable with respect to the manufacturing process and environmental factors. The complexity and heterogeneity of the molecular structure, complicated manufacturing process, different analytical methods, and possibility of severe immunogenicity reactions make quantitative evaluation of biosimilar products a great challenge to both the scientific community and regulatory agencies. The purpose of this Special Issue is not only to create a discussion forum by inviting relevant research work on the design and analysis of biosimilar studies, but also to reflect recent discussion/development from the pharmaceutical/biotechnology industry, academia, and regulatory agencies such as EU European Medicines Agency and US FDA. As a highly regarded journal, GaBI Journal will help achieve these professional objectives.

Please view the published manuscripts under this educational series:

Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act

Biosimilarity in Latin America

Assessing biosimilarity using the method of generalized pivotal quantities

Establishment of reference standards in biosimilar studies

Immunogenicity of biosimilar monoclonal antibodies

Statistical considerations for the development of biosimilars

Interchangeability. An insurmountable fifth hurdle?

Guest Editor: Professor Shein-Chung Chow, PhD, Duke University School of Medicine, Durham, North Carolina, USA

For further information on the editorial topics, please contact the Publisher.

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Generics and Biosimilars Initiative (GaBI)
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