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Page 59
allied
academies
Asian Journal of Biomedical and Pharmaceutical Sciences | Volume 8
March 26-27, 2018 | Orlando, USA
World Summit on
Healthcare & Hospital Management
&
International Conference & Exhibition on
Biologics and Biosimilars
T
here is a fundamental difference between Generics and
Biosimilars. “A generic drug is identical or bioequivalent
to a brand name drug in dosage form, safety, strength,
route of administration, quality, performance characteristics
and intended use.” About a Biosimilar, small differences in
structure or chemistry due to the processes and chemicals
used in the culture, purification, storage, etc., may result in
differences in efficacy, safety and immunological outcomes
as compared to a Biologic. As such, Biosimilars, are in many
ways analogous to generics, but are not generic drugs. The
question is, “Can the need for preclinical and clinical studies
be eliminated in case of Biosimilars before they are put to
therapeutic use”? The issue is intricate attracting different
viewpoints and it is currently not clear if separate evidence
for each indication will be required. The approach so far
adopted in the USA and Europe has been heterogeneous
and the matter needs to be studied in-depth. In this
paper, I examine the issue from multiple perspectives i.e.,
the academic, industry, regulatory agencies, patients and
clinicians in an attempt to search a holistic solution.
e:
rrkishore@vsnl.comFrom brand vs. generic to biologic vs. biosimilar: The regulatory challenge and the search for a holistic
solution
R R Kishore
Indian Society for Health Laws and Ethics, India