Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America
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1 novembre 2016
- handle: 10670/1.one5ox
Ce document est lié à :
10.1016/j.ejbt.2016.10.003
info:eu-repo/semantics/openAccess
Mots-clés
Bio therapeutic Comparability Critical quality attributes Developing countries Generics Health policies High quality biosimilars RegulationSujets proches
Underdeveloped countries Third World Emerging nations NICs (Newly industrialized countries) Fourth World Global South Underdeveloped areas Newly industrialized countries Least developed countries LDC's Less developed countries Newly industrializing countriesCiter ce document
Karina Mendoza-Macedo et al., « Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America », Electronic Journal of Biotechnology, ID : 10670/1.one5ox
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Résumé
Background: Developing countries have an estimate of ten times more approved biosimilars than developed countries. This disparity demands the need of an objective regulation that incorporates health policies according to the technological and economical capabilities of each country. One of the challenges lies on the establishment of comparability principles based on a physicochemical and biological characterization that should determine the extent of additional non-clinical and clinical studies. This is particularly relevant for licensed biosimilars in developing countries, which have an extensive clinical experience since their approval as generics' in some cases more than a decade. To exemplify the current status of biosimilars in Mexico' a characterization exercise was conducted on licensed filgrastim biosimilars using pharmacopeial and extended characterization methodologies. Results: Most of the evaluated products complied with the pharmacopeial criteria and showed comparability in their Critical Quality Attributes (CQAs) towards the reference product. These results were expected in accordance with their equivalent performance during their licensing as generics. Accordingly' a rational approval and registration renewal scheme for biosimilars is proposed, that considers the proper identification of CQAs and its thoroughly evaluation using selected techniques. Conclusions: This approach provides support to diminish uncertainty of exhibiting different pharmacological profiles and narrows or even avoids the necessity of comparative clinical studies. Ultimately, this proposal is intended to improve the accessibility to high quality biosimilars in Latin America and other developing countries.