A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in healthy adults-Reference-Cited by-同舟云学术

A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in healthy adults

Published:2023-05-04 Issue:5 Volume:32 Page:417-427
ISSN:1354-3784
Container-title:Expert Opinion on Investigational Drugs
language:en
Short-container-title:Expert Opinion on Investigational Drugs

Author:

Wynne Christopher¹,Hamilton Paul²,McLendon Kristi³,Stroissnig Heimo⁴,Smith Matthew⁵,Duijzings Paul⁵,Ruffieux Ruth⁵,Otto Hendrik⁴,Sattar Abid⁶,Haliduola Halimu N.⁴,Leutz Steffen⁴,Berti Fausto⁵

Affiliation:

1. New Zealand Clinical Research, Christchurch, New Zealand

2. New Zealand Clinical Research, Auckland, New Zealand

3. Nucleus Network Pty Ltd, Herston, Australia

4. Alvotech Germany GmbH, Jülich, Germany

5. Alvotech Swiss AG, Zürich, Switzerland

6. Alvotech UK Ltd, London, UK

Funder

Alvotech Swiss AG, Zürich, Switzerland

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/13543784.2023.2215426

Reference18 articles.

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3. FDA. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product – Guidance for Industry. Apr 2015. (https://www.fda.gov/media/82647/download) Accessed 27 Mar 2023.

4. EMA. Guideline on similar biological medicinal products. Apr 2015. (https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf) Accessed 27 Mar 2023.

5. WHO. Guidelines on evaluation of similar biotherapeutic products (SBPs). Jan 2010. (https://cdn.who.int/media/docs/default-source/biologicals/trs_977_annex_2.pdf?sfvrsn=e2389a69_3&download=true). Accessed 27 Mar 2023.

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