Development of biosimilars in Mexico


The pathway for the approval of biosimilars includes an exhaustive characterization and a comprehensive comparability study, including non-clinical and clinical stages to demonstrate similarity in quality and pharmacological behavior to the reference product. Herein we review the key points in the approval pathway of biosimilars through the identification of the critical quality attributes (cqas) towards obtaining a desired product throughout in-process controls and the identification of critical process parameters (cpps). In the case of biosimilars, similarity against the reference product is achieved based on a quality target product profile (qtpp) that allows knowing the batch-to-batch oscillation and distribution of the cqas of the reference product. For the evaluation of cqas it is important to include orthogonal analytical techniques to provide certainty to the results. The collective information obtained from the physicochemical characterization, as well as from non-clinical studies; provide scientific evidence that contribute to the design of clinical comparative studies .

KEYWORDS: Biosimilars · Biologics Critical quality attributes Characterization