Conference Dates
May 8-13, 2016
Abstract
Regulatory guidance documents clearly outline the requirements for demonstrating analytical comparability to support process changes and analytical similarity to support the approval of biosimilars. These include demonstration that process changes do not produce differences in product characteristics that might lead to an adverse impact on the safety or efficacy of the product1. For biosimilar products, a stepwise approach is required that starts with sponsors demonstrating that the product characteristics of the proposed biosimilar are either highly similar to that of the originator reference product or that any observed differences can be demonstrated to not impact the ability to leverage (or “conserve”) the safety and efficacy profile previously demonstrated by the originator2. Some product characteristics are however uniquely sensitive to small changes in process conditions, including but not limited to isoform charge distribution and glycan profiles. Moreover, as analytical methods continue to evolve, the ability to quantitatively detect small changes in these characteristics continues to improve. As such, every biotechnologist is faced with the question of what is comparable enough and/or what is similar enough. The author will review twenty years of regulatory feedback on these questions and discuss how regulatory agencies in the major markets have answered these same questions
Recommended Citation
1. FDA Guidance for Industry: “Comparability Protocols – Protein Drug Products and Biologics Products – Chemistry, Manufacturing and Controls Information” September 2003; ICH Guidance Q5E: “Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process” 2. FDA Guidance for Industry: “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”, September 2012; CHMP: “Guideline on similar biologic medicinal products containing monoclonal antibodies – non-clinical and clinical issues”; 30MAY2012