1 research outputs found
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 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