TY - JOUR
T1 - Characterization and comparability of biosimilars
T2 - A filgrastim case of study and regulatory perspectives for Latin America
AU - Mendoza-Macedo, Karina
AU - Romero-Díaz, Alexis J.
AU - Miranda-Hernández, Mariana P.
AU - Campos-García, Víctor R.
AU - Ramírez-Ibañez, Nancy D.
AU - Juárez-Bayardo, L. Carmina
AU - Moreno-Duran, Karen
AU - Cedillo-Robles, Miriam S.
AU - Pérez, Nestor O.
AU - Jung-Cook, Helgi
AU - Flores-Ortiz, Luis F.
AU - Medina-Rivero, Emilio
N1 - Publisher Copyright:
© 2016 Pontificia Universidad Católica de Valparaíso. Production and hosting by Elsevier B.V. All rights reserved.
PY - 2016
Y1 - 2016
N2 - 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.
AB - 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.
KW - Bio therapeutic
KW - Comparability
KW - Critical quality attributes
KW - Developing countries
KW - Generics
KW - Health policies
KW - High quality biosimilars
KW - Regulation
UR - http://www.scopus.com/inward/record.url?scp=84995602256&partnerID=8YFLogxK
U2 - 10.1016/j.ejbt.2016.10.003
DO - 10.1016/j.ejbt.2016.10.003
M3 - Artículo
SN - 0717-3458
VL - 24
SP - 63
EP - 69
JO - Electronic Journal of Biotechnology
JF - Electronic Journal of Biotechnology
ER -