Biosimilars: The Process & Quality System Approach to Clinical Applications | Abstract

Asploro Journal of Biomedical and Clinical Case Reports

Asploro Journal of Biomedical and Clinical Case Reports

ISSN: 2582-0370

Article Type: Review Article

DOI: 10.36502/2020/ASJBCCR.6183

Asp Biomed Clin Case Rep. 2020 Jan 29;3(1):33-41

Aziz KJ1*
1Former Associate Director, CDRH, U.S. Food and Drug Administration, (FDA), USA

Corresponding Author: Kaiser Jay Aziz, MB, MS, PhD, FACB, FACS ORCID ID
Address: Managing Director, Grand Medical Institute LLC, Bowie, Maryland, USA.
Received date: 23 December 2019; Accepted date: 21 January 2020; Published date: 29 January 2020

Citation: Aziz KJ. Biosimilars: The Process & Quality System Approach to Clinical Applications. Asp Biomed Clin Case Rep. 2020 Jan 29;3(1):33-41.

Copyright © 2020 Aziz KJ. This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium provided the original work is properly cited.

Keywords: Biosimilars, Drugs, Filgrastim, Oncology


Biosimilar medicines are highly similar to FDA approved reference biologics. The sponsor’s intended use claim plays an important role in the use of biosimilar medicines in specialty therapy categories such as immunology, endocrinology, oncology. The new biosimilar products approved by the FDA, play a pivotal role in the clinical treatments of patients suffering from life-threatening diseases such as cardiac myopathies, carcinoma, sarcoma, lymphoma. The US biosimilar approval process requires a thorough characterization of the new biosimilars with a clinically meaningful outcome. Sponsors of new biosimilars follow the appropriate ICH guidelines in regard to clinical PK/PD, safety and efficacy studies. The FDA guidances for extrapolation and interchangeability state that data derived from clinical studies should be adequate to demonstrate purity, potency, safety and the intended clinical use of the new biosimilar in comparison to previously approved licensed biologics. This article emphasizes the FDA’s quality system approach to the design of studies for clinical applications for designated specialty therapy categories.



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