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Br J Dermatol. 2016 Feb;174(2):282-6. doi: 10.1111/bjd.14267. Epub 2015 Dec 30.

Biosimilars for psoriasis: preclinical analytical assessment to determine similarity.

Author information

1
Oregon Medical Research Center, Portland, OR, U.S.A.
2
Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
3
Department of Quality Measurements and Research, Chief Physician's Office, Clalit Health Services, Tel Aviv, Israel.
4
Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
5
Dermatrials Research Inc., 132 Young Street, Hamilton, ON, Canada, L8N 1V6.
6
International Psoriasis Council, St Louis, MO, U.S.A.
7
Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, 1515 North Vermont Avenue, 5th Floor, Los Angeles, CA, 90027, U.S.A.

Abstract

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.

Comment in

PMID:
26522054
DOI:
10.1111/bjd.14267
[Indexed for MEDLINE]

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