8 BioPharm International eBook October 2018 www.biopharminternational.com
tilialucida\adobe.com
An Analytical Approach to
Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar
and the reference product is a primary consideration in the
development of biosimilars.
T
he long-ter m safet y and eff icac y of bio -
similars are largely based on clinical studies
that have already been conducted on the
reference biologic, but these studies may
not always be sufficient to ensure that the
biosimilar can comparably replace the reference
product. Having an analytical strategy to compare
the physicochemical properties of a biosimilar to
its reference product can therefore provide impor-
tant clinical data to indicate that clinical similarity
exists in safety and efficacy between the two. As
such, providing data on the physicochemical com-
parison between biosimilar and reference product
becomes a primary consideration during biosimilar
development (1).
Analy tical chemists, however, are increasingly
challenged to develop routine and automated char-
acterization workflows for innovator and biosimi-
lar biologics that can move these products forward
through the development stages and into commercial-
ization. Although analytical scientists have long been
immersed in the traditional field of small-molecule
pharmaceuticals, they are increasingly required to
shift focus to large-molecule characterization and
analysis with the growth of biotherapeutics in the
pharmaceutical industry pipleline (2).
FELIZA MIRASOL
Biopharma Laboratory Best Practices Biosimilar Analysis
