By: Alexandra Sklan, Future Science Group
Guest edited by Lakshmi Amaravadi (Biogen Idec) and Joe Marini (Johnson and Johnson), Bioanalysis has published a special focus issue on the bioanalysis of biosimilars. This issue discusses the challenges faced in the development and validation of bioanalytical methods to assess biosimilar products.
With the EU issuing a guidance on the approval of biosimilars back in 2005 and the US FDA drafting three guidances late last year in response to the 2010 Biologics Price Competition and Innovation Act, current thinking on the key scientific and regulatory factors regarding follow-on biologics is currently under rigorous consideration by manufacturers.
Despite the European Medicines Agency and the FDA draft guidances, however, there is a lack of regulatory guidance regarding the requirements for the bioanalytical testing of biosimilars and innovator biologics in comparability studies that support the development of these follow-on biologics.
Lakshmi Amaravadi and Joe Marini highlight the importance of this timely and topical area in their Foreword. “Given the complexity of biologic therapies and analytical methods associated with [biosimilars]and the potential impact they could have on making inference around similarity or dissimilarity of a biologic to a reference compound, it is important to examine [the issue of biosimilarity]carefully.”
With a selection of absorbing articles including Perspectives to Reviews and Primary Research papers to Editorials, topics from this issue include the use of PK and anti-drug antibody assays to support pre-clinical and clinical comparability studies, the issue of suitability and selection of reference standards and comparators in support of biosimilar drug development and the regulatory and bioanalytical considerations of assessing the immunogenicity of biosimilars.
As the Guest Editors explain, “This issue of Bioanalysis presents a special focus on the bioanalysis of biosimilars and challenges related to non-clinical and clinical development. A wide variety of experts in the field present their science and opinions to help us gain knowledge on the issues and challenges associated with the development of biosimilars.”
With bioanalytical validation and development of follow-on biologics still in its infancy, it is imperative that the wider community share their thoughts and perspectives on this timely and topical area of drug development.