Biosimilars for psoriasis: preclinical analytical assessment to determine similarity-Reference-Cited by-同舟云学术

Biosimilars for psoriasis: preclinical analytical assessment to determine similarity

Published:2015-12-30 Issue:2 Volume:174 Page:282-286
ISSN:0007-0963
Container-title:British Journal of Dermatology
language:en
Short-container-title:Br J Dermatol

Author:

Blauvelt A.¹,Cohen A.D.²³,Puig L.⁴,Vender R.⁵,van der Walt J.⁶,Wu J.J.⁷

Affiliation:

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

Funder

AbbVie

Amgen

Centocor-Ortho Biotech

Janssen-Cilag

Wyeth

Publisher

Wiley

Subject

Dermatology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/bjd.14267/fullpdf

Reference25 articles.

1. Biosimilars - why terminology matters;Weise;Nat Biotechnol,2011

2. U.S. Department of Health and Human Services Food and Drug Administration Scientific considerations in demonstrating biosimilarity to a reference product http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf

3. Biopharmaceuticals and biosimilars in psoriasis: what the dermatologist needs to know;Strober;J Am Acad Dermatol,2012

4. Nonclinical development of a biosimilar: the current landscape;O'Connor;Bioanalysis,2013

5. U.S. Department of Health and Human Services Food and Drug Administration Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf

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