A case study: Scientific challenges for bioanalytical method development of biosimilars

5^th European Biosimilars Congress

June 27-29, 2016 Valencia, Spain

Rafiq Islam

Celerion Inc., USA

Posters & Accepted Abstracts: J Bioanal Biomed

Abstract :

According to recent FDA guidance, a Biosimilar is a biological product which is shown to be highly similar to the reference product not withstanding minor differences in clinically inactive components. It is essential to demonstrate that there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency. Accurate and reliable bioanalytical and immunogenicity data are critical to demonstrating safety and efficacy of biosimilar and to show comparability between innovator and Biosimilar. Demonstration of comparability between biosimilar and innovator compound could be challenging due to different methods used to establish the strength of the drugs. This may lead to significantly different concentrations between biosimilar and innovator drug. Cell-based potency assays may not be able to detect differences between biosimilar and innovator due to wide acceptance ranges (70% to 130%) used in these assays. If the concentration differences cannot be resolved, it may require two assays to measure pharmacokinetic samples for innovator and biosimilar drugs. Use of two separate assays may indicate that the two products are significantly different and necessitate analysis of both compounds using both assays. Proving similarity of the immunogenicity of the biosimilar and innovator can also be quite challenging due to the fact that these types of assays are generally qualitative. The rate of immunogenicity can be particularly difficult when the incidence of positive response is low. In addition, a small process changes during the manufacturing of therapeutic proteins may lead to significant changes in the rate of immunogenicity. Due to these reasons, it is necessary to develop two robust immunogenicity assays, one for biosimilar and one for innovator, with comparable sensitivity, precision, specificity and drug tolerance. Our labs recently developed bioanalytical assays to support biosimilars of Forsteo�® (also known as Forteo�®). This presentation will explore above challenges and present solutions using Forsteo�® assays as a case study.

Biography :

Email: Rafiqul.islam@Celerion.com