The biosimilar development process occurs in three major stages: This includes extensive analytical testing, preclinical studies, and clinical trials. As a first step, the quality profile of the reference product needs to be analysed in detail, in order to establish a highly similar profile of the biosimilar.
Anna Faith Scrolller
Similarity testing occurs multiple times throughout the development process. As the patent and exclusivity period for biological medicines draws to a close, there is a possibility for the development and authorization of biosimilars. The development of biosimilars involves a rigorous process to ensure they are highly similar to the original biologic.
The goal of a biosimilar development program is to use a “totality of the evidence” approach to demonstrate biosimilarity to the reference product, not to independently establish safety and.
Selected clone with matching critical quality attributes fermentation: Biosimilar manufacturers conduct batch analyses of multiple batches of the originator biologic medicine, perform analytical and functional characterizations, and upstream and downstream. From cell clone to antibody manufacturing clone selection: These products boast comparable levels.
Learn how biosimilars are developed through a rigorous process requiring substantial time and financial investment.
