Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis-Reference-Cited by-同舟云学术

Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis

Published:2017-12 Issue:6 Volume:177 Page:1562-1574
ISSN:0007-0963
Container-title:British Journal of Dermatology
language:en
Short-container-title:Br J Dermatol

Author:

Papp K.¹²,Bachelez H.³,Costanzo A.⁴,Foley P.⁵⁶⁷,Gooderham M.²⁸,Kaur P.⁹,Philipp S.¹⁰,Spelman L.¹¹¹²,Zhang N.⁹,Strober B.¹³¹⁴

Affiliation:

1. Clinical Research; Waterloo ON Canada

2. Probity Medical Research; Waterloo ON Canada

3. Sorbonne Paris Cité Université Paris Diderot; Department of Dermatology; AP-HP HP Hôpital Saint-Louis; INSERM U1163; Institut Imagine; Paris France

4. Dermatology Unit; Department of Biomedical Sciences; Humanitas University; Rozzano - Milan Italy

5. Department of Medicine (Dermatology); The University of Melbourne; St Vincent's Hospital Melbourne; Australia

6. Skin & Cancer Foundation Inc.; Carlton Australia

7. Probity Medical Research; Carlton Australia

8. SKiN Centre for Dermatology; ON Canada

9. Amgen Inc.; Thousand Oaks CA U.S.A

10. Psoriasis Research and Treatment Center; University Hospital Charité; Berlin Germany

11. Veracity Clinical Research; Woolloongabba Queensland Australia

12. Probity Medical Research; Woolloongabba Queensland Australia

13. University of Connecticut Health Center; Farmington CT U.S.A

14. Probity Medical Research; Farmington CT U.S.A

Funder

Amgen

Publisher

Wiley

Subject

Dermatology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/bjd.15857/fullpdf

Reference39 articles.

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2. European Medicines Agency Guideline on similar biological medicinal products http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf

3. European Medicines Agency Committee for Medicinal Products for Human Use Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf

4. US Department of Health and Human Services Scientific considerations in demonstrating biosimilarity to a reference product http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf

5. US Food and Drug Administration FDA approves Inflectra, a biosimilar to Remicade http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm

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