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THE PHARMA REVIEW (JAN FEB 2019)

Challenges and Opportunities in Regulatory Affairs of Biotherapeutics

Jovita Kanoujia & Anantha Naik Nagappa*

Introduction:

Abstract: Biologicals were introduced to the therapeutics early in 1923, by introducing insulin by Banting and Macleod in Canada. There are no further advancement until 2000, when human genome was decoded. Biotechnologies technique cDNA, hybridoma were exclusively used for inventing biotherapeutics, biosilmilar and biobetters. The biotherapeutics being sophisticated medicines require high end technology inputs which makes them very expensive. They are almost targeted drug deliveries acting by manipulation of immune systems which are devoid of adverse drug reactions (ADRs) that is observed in small molecules or synthetic chemical drugs. Recently, programmed cell death ligands (PD-1), programmed death ligand 1 receptors (PDL-1) and chimeric antigen receptors (CAR-T) comes up with revolutionary changes in cancer and other diseases.

 

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