QUALITY EVALUATION OF BIOSIMILAR MEDICINES: AN OVERVIEW

Abstract

Biosimilar medicines are biotherapeutics that are similar in quality, safety and efficacy to previously licensed reference biotherapeutics. The slightest change in any stage of production can cause differences in the product. Among the factors, affecting production can be listed as; host cell selection, fermenter type, ambient conditions, broth, substances used for cell culture, fermentation method and purification method. The similarity should be demonstrated by comparative quality, non-clinical and clinical tests. Research and development studies in the biopharmaceutical field bring diversity of quality control methods along with the formulation and manufacturing method of the biosimilars. Although there are some standardized and validated quality control methods given in the internationally recognized pharmacopoeias, there are many in house methods of biopharmaceutical product owners that can only be used as internal quality control methods by them. The main international sources for quality control methods of biopharmaceutics can be given as pharmacopoeias, International Organization for Standardization standards and Organization for Economic Co-operation and Development methods. In this review manufacturing process, regulatory guidelines and quality control of biosimilar medicines briefly are given.


Peer Review History:


Received 11 March 2019; Revised 20 April; Accepted 3 May, Available online 15 May 2020


UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency.


Received file


pdf3.JPG


Average Peer review marks at initial stage: 6.0/10


Average Peer review marks at publication stage: 7.5/10


Reviewer(s) detail:


Name: Dr. Mohamed Salama


Affiliation: Modern University for Technology & Information, Egypt


E-mail: salama47@yahoo.com


 


Name: Dr.  Maha Khalifa Ahmed Khalifa


Affiliation:


E-mail: mahakhalifa.ahmed@hotmail.com


Comments of reviewer(s):


word_icon_3.jpg

Keywords: Biosimilars, biotherapeutics, manufacturing, quality control, pharmacopoeial methods
Statistics
36 Views | 36 Downloads
How to Cite
KORKMAZ, E., M. E. ÖZDEMİRHAN, and E. A. YAPAR. “QUALITY EVALUATION OF BIOSIMILAR MEDICINES: AN OVERVIEW”. Universal Journal of Pharmaceutical Research, Vol. 5, no. 2, May 2020, doi:https://doi.org/10.22270/ujpr.v5i2.390.
Section
Review Articles