Premium
Biosimilars for psoriasis: preclinical analytical assessment to determine similarity
Author(s) -
Blauvelt A.,
Cohen A.D.,
Puig L.,
Vender R.,
Walt J.,
Wu J.J.
Publication year - 2016
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.14267
Subject(s) - biosimilar , psoriasis , medicine , quality (philosophy) , risk analysis (engineering) , product (mathematics) , similarity (geometry) , biological drugs , pharmacology , intensive care medicine , business , computer science , immunology , disease , artificial intelligence , philosophy , geometry , mathematics , epistemology , image (mathematics)
Summary Biosimilars, sometimes called ‘generic biologics’, are no longer a vision for the future but a present‐day reality. Drug manufacturers and regulatory authorities are charged with ensuring that these products are safe and effective. Because biologically produced medications are large, complex proteins, many factors affect the quality of the end product, including glycosylation and presence of impurities, and thus many factors need to be compared between an emerging biosimilar and its originator biologic. Indeed, preclinical analytical assessments to determine similarity to an originator biologic are critical and are considered to be the foundation for regulatory approval of biosimilars. Here, the science behind the preclinical development of biosimilars is discussed by members of the International Psoriasis Council, and suggestions are put forth to try to ensure that future biosimilars are produced in a high quality and standardized manner.