healthcare-biosimilars-2018-posters-accepted-abstracts

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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

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.

From 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