Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis-Reference-Cited by-同舟云学术

Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis

Published:2023-07-12 Issue:8 Volume:23 Page:759-771
ISSN:1471-2598
Container-title:Expert Opinion on Biological Therapy
language:en
Short-container-title:Expert Opinion on Biological Therapy

Author:

Feldman Steven R¹²,Reznichenko Nataliya³,Berti Fausto⁴,Duijzings Paul⁴,Ruffieux Ruth⁴,Otto Hendrik⁵,Haliduola Halimu N⁵,Leutz Steffen⁵,Stroissnig Heimo⁵

Affiliation:

1. Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, USA

2. Department of Dermatology, The University of Southern Denmark, Odense, Denmark

3. Military Hospital (Military Unit A3309) of Military-Medical Clinical Center of Eastern Region, Zaporizhzhia, Ukraine

4. Alvotech Swiss AG, Zürich, Switzerland

5. Clinical and Medical Affairs, Alvotech Germany GmbH, Jülich, Germany

Funder

Alvotech Swiss AG, Zürich, Switzerland

Publisher

Informa UK Limited

Subject

Clinical Biochemistry,Drug Discovery,Pharmacology

Link

https://www.tandfonline.com/doi/pdf/10.1080/14712598.2023.2235263

Reference27 articles.

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2. Pharmaceuticals and Medical Devices Agency (PMDA). Report On The Deliberation Results. 17 Feb 2017; [cited 09 May 2023]. https://www.pmda.go.jp/files/000227668.pdf

3. EPAR EMA. [cited 12 May 2015]. https://www.ema.europa.eu/en/documents/product-information/stelara-eparproduct-information_en.pdf

4. FDA. Stelara US-Prescribing Information. [cited 12 May 2015]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s150lbl.pdf

5. Xian, Janssen. Stelara Chinese product information. [cited 12 May 2015]. https://www.xian_janssen.com.cn/sites/default/files/PDF/13fu_jian_wu_si_nu_dan_kang_zhu_she_ye_shuo_ming_shu__20200311.pdf

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3. Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments;Pharmaceutical Medicine;2024-04-29

4. Biosimilars approved for psoriasis treatment in Europe;PONS - medicinski casopis;2023