edición biomedicina
Miranda Hernández M. P. et al. Entorno udlap, núm. 4, 4-9, Enero 2018
IN
1993
4
development of
biosimilars
50 biopharmaceutical drug products were approved by the Mexican Ministry of Health.
5
Mexico became a leader in Latin America in the development of biopharmaceuticals for over two decades.
Por:
www.udlap.mx
in mexico
Mariana P. Miranda Hernández · Carlos A. López Morales · Luis F. Flores Ortiz · Emilio Medina Rivero
ABSTRACT
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 (cqa s) towards obtaining a desired product throughout in-process controls and the identification of critical process parameters (cpp s). 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 cqa s 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
INTRODUCTION
Mexico became a leader in Latin America in the development of biopharmaceuticals for over two decades, since interferon alpha-2b was introduced into the national market in 1993. This was the first recombinant biopharmaceutical product manufactured in Mexico by Probiomed S. A. de C. V. Subsequently, more than 50 biopharmaceutical drug products were approved by the Mexican Ministry of Health (Secretaría de Salud) through the Federal Commission for the Protection against Sanitary Risk (cofepris ) as generics under the law that was effective until 2012, when an updated regulation specific for the approval of biosimilars was issued. According to the updated regulation, the pathway for biosimilars approval begins with an exhaustive characterization of the product and a comprehensive compara-
Miranda Hernández M. P. et al. (2018). Development of biosimilars in Mexico. Entorno UDLAP, 4. Recibido: 16 de junio de 2017. Aceptado: 9 de octubre de 2017.
For the evaluation of CQAs it is important to include orthogonal analytical techniques to provide certainty to the results.
THE AIM OF THIS DOCUMENT IS TO REVIEW KEY POINTS AT EACH OF THE STAGES OF THIS APPROVAL PATHWAY THROUGH THE IDENTIFICATION OF THE CRITICAL QUALITY ATTRIBUTES (CQAs) OF THE BIOPHARMACEUTICAL PRODUCT, WHICH IMPACT ON ITS SAFETY AND EFFICACY.