Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America
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 chall...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2016-11-01
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| Series: | Electronic Journal of Biotechnology |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0717345816300987 |
| _version_ | 1811304236374294528 |
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| author | Karina Mendoza-Macedo Alexis J. Romero-Díaz Mariana P. Miranda-Hernández Víctor R. Campos-García Nancy D. Ramírez-Ibañez L. Carmina Juárez-Bayardo Karen Moreno-Duran Miriam S. Cedillo-Robles Nestor O. Pérez Helgi Jung-Cook Luis F. Flores-Ortiz Emilio Medina-Rivero |
| author_facet | Karina Mendoza-Macedo Alexis J. Romero-Díaz Mariana P. Miranda-Hernández Víctor R. Campos-García Nancy D. Ramírez-Ibañez L. Carmina Juárez-Bayardo Karen Moreno-Duran Miriam S. Cedillo-Robles Nestor O. Pérez Helgi Jung-Cook Luis F. Flores-Ortiz Emilio Medina-Rivero |
| author_sort | Karina Mendoza-Macedo |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T08:03:20Z |
| format | Article |
| id | doaj.art-4ca70705dc294e1893a489a7491d6c0d |
| institution | Directory Open Access Journal |
| issn | 0717-3458 |
| language | English |
| last_indexed | 2024-04-13T08:03:20Z |
| publishDate | 2016-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Electronic Journal of Biotechnology |
| spelling | doaj.art-4ca70705dc294e1893a489a7491d6c0d2022-12-22T02:55:14ZengElsevierElectronic Journal of Biotechnology0717-34582016-11-0124C636910.1016/j.ejbt.2016.10.003Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin AmericaKarina Mendoza-Macedo0Alexis J. Romero-Díaz1Mariana P. Miranda-Hernández2Víctor R. Campos-García3Nancy D. Ramírez-Ibañez4L. Carmina Juárez-Bayardo5Karen Moreno-Duran6Miriam S. Cedillo-Robles7Nestor O. Pérez8Helgi Jung-Cook9Luis F. Flores-Ortiz10Emilio Medina-Rivero11Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Av. Universidad 3000, Coyoacán, Ciudad de México, C.P. 04510, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, Tenancingo, Estado de México, C. P. 52400, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, Tenancingo, Estado de México, C. P. 52400, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, Tenancingo, Estado de México, C. P. 52400, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, Tenancingo, Estado de México, C. P. 52400, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, Tenancingo, Estado de México, C. P. 52400, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, Tenancingo, Estado de México, C. P. 52400, MexicoUnidad de Calidad, Probiomed S.A. de C.V., San Esteban No. 88, Azcapotzalco, Ciudad de México, C.P. 02020, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, Tenancingo, Estado de México, C. P. 52400, MexicoDepartamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Av. Universidad 3000, Coyoacán, Ciudad de México, C.P. 04510, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, Tenancingo, Estado de México, C. P. 52400, MexicoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán s/n, Tenancingo, Estado de México, C. P. 52400, MexicoBackground: 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.http://www.sciencedirect.com/science/article/pii/S0717345816300987Bio therapeuticComparabilityCritical quality attributesDeveloping countriesGenericsHealth policiesHigh quality biosimilarsRegulation |
| spellingShingle | Karina Mendoza-Macedo Alexis J. Romero-Díaz Mariana P. Miranda-Hernández Víctor R. Campos-García Nancy D. Ramírez-Ibañez L. Carmina Juárez-Bayardo Karen Moreno-Duran Miriam S. Cedillo-Robles Nestor O. Pérez Helgi Jung-Cook Luis F. Flores-Ortiz Emilio Medina-Rivero Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America Electronic Journal of Biotechnology Bio therapeutic Comparability Critical quality attributes Developing countries Generics Health policies High quality biosimilars Regulation |
| title | Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America |
| title_full | Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America |
| title_fullStr | Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America |
| title_full_unstemmed | Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America |
| title_short | Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America |
| title_sort | characterization and comparability of biosimilars a filgrastim case of study and regulatory perspectives for latin america |
| topic | Bio therapeutic Comparability Critical quality attributes Developing countries Generics Health policies High quality biosimilars Regulation |
| url | http://www.sciencedirect.com/science/article/pii/S0717345816300987 |
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