On January 23rd I’ll be hosting a webinar with Dr. Dominque Gouty that will summarize key insights from the recently published paper by the American Association of Pharmaceutical Scientists (AAPS) entitled “Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs”. I had the privilege to contribute as an author on this pivotal paper, which lays out a consensus recommendation for use of a one-assay approach to develop and validate ADA assays supporting biosimilar drug development programs.
It has taken years of industry discussion and collaboration across scientists and health agencies to reach this important consensus milestone. While best practices around bioanalytical strategies to support development of biosimilars have evolved, regulatory guidance in this area is still lacking. It is our hope that the AAPS paper will help to shape future regulatory guidelines and ensure efficient, safe development of biosimilars that can increase patient access to the drugs they need.
In the webinar we will go into more detail as to why both US– and European-based regulators agree that a one-assay approach is ideal for immunogenicity assessments of biosimilars and reference biologics in comparability studies, touching on:
Requirements for Immunogenicity Assessments of Biosimilars in the Clinical Setting
The demonstration of similar immunogenicity is a critical requirement for the demonstration of similarity between a biosimilar candidate and its originator product. Head-to-head clinical studies must be performed to assess potential differences in the immunogenic profiles of the two products.
The approach to developing and validating ADA assays to support evaluation of immunogenicity for a biosimilar should include all the assessments recommended for an innovator program. In addition, specific parameters also need to be evaluated with both the biosimilar and the originator product to ensure the assay’s ability to similarly detect antibodies against both products, and demonstrate each product’s similar reactivity with the positive control. This makes development and validation of ADA assays supporting biosimilars more complex – and made harder by a lack of clear guidance.
Challenges that the One-Assay Approach Can Address
The use of two independent assays to assess immunogenicity of a biosimilar and its originator product will inevitably lead to discrepancies in assay characteristics because different reagents are used. This creates significant additional work to generate acceptance criteria that are similar for both assays.
The one-assay approach eliminates “between-assay” variability to uphold uniformity and reduce assay bias. It also streamlines the time and effort needed to conduct validation, and drives operational simplicity in supporting the unequivocal clinical determination of similar immunogenicity between a biosimilar candidate compared to its originator.
Join the BioAgilytix Webinar to Learn More
Thursday, January 23, 2019 at 10:00 AM EDT / 15:00 BST / 7:00 AM PST
We’ll discuss additional advantages of a one-assay approach as well as share practical guidance on the development and validation of ADA assays used to support biosimilar programs. Don’t miss your chance to hear our firsthand insights! Register through Bioanalysis Zone here.