Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice

Author:

Cohen A.D.12ORCID,Wu J.J.3,Puig L.4ORCID,Chimenti S.5,Vender R.6ORCID,Rajagopalan M.7,Romiti R.8,de la Cruz C.9,Skov L.10,Zachariae C.10,Young H.S.1112ORCID,Foley P.131415,van der Walt J.M.16ORCID,Naldi L.17,Prens E.P.18,Blauvelt A.19ORCID

Affiliation:

1. Siaal Research Center for Family Medicine and Primary Care; Faculty of Health Sciences; Ben-Gurion University of the Negev; Beer-Sheva Israel

2. Department of Quality Measurements and Research; Chief Physician's Office, Clalit Health Services; Tel Aviv Israel

3. Department of Dermatology; Kaiser Permanente Los Angeles Medical Center; Los Angeles CA U.S.A.

4. Department of Dermatology; Hospital de la Santa Creu i Sant Pau; Universitat Autònoma de Barcelona; Barcelona Spain

5. University of Rome Tor Vergata; Rome Italy

6. Dermatrials Research Inc. & Venderm Innovations in Psoriasis; Hamilton ON Canada

7. Department of Dermatology; Apollo Hospitals; Chennai India

8. Department of Dermatology; University of São Paulo; São Paulo Brazil

9. Clínica Dermacross; Santiago Chile

10. Department of Dermatology and Allergy, Herlev and Gentofte Hospital; University of Copenhagen; Copenhagen Denmark

11. The University of Manchester; Manchester Academic Health Science Centre; Manchester U.K.

12. Department of Dermatology; Salford Royal NHS Foundation Trust; Manchester U.K.

13. Skin & Cancer Foundation Inc.; Carlton Vic. Australia

14. Department of Dermatology; The University of Melbourne; Melbourne Vic. Australia

15. St Vincent's Hospital; Melbourne Vic. Australia

16. International Psoriasis Council; St Louis MO U.S.A.

17. Department of Dermatology; Azienda Ospedaliera Papa Giovanni XXIII; Bergamo Italy

18. Deptartment of Dermatology; Erasmus MC; P.O. Box 5201 3008 AE Rotterdam the Netherlands

19. Oregon Medical Research Center; Portland OR U.S.A.

Funder

AbbVie

Amgen

Centocor Ortho Biotech

Janssen-Cilag

Wyeth

Publisher

Wiley

Subject

Dermatology

Reference62 articles.

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

2. U.S. Department of Health and Human Services Food and Drug Administration: Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product: Guidance for Industry www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM397017.pdf

3. The cost of biologics for psoriasis is increasing;Cheng;Drugs Context,2014

4. Are patients with psoriasis undertreated? Results of National Psoriasis Foundation survey;Horn;J Am Acad Dermatol,2007

5. Biological therapies for psoriasis;Mansouri;Expert Opin Biol Ther,2013

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