Pharmacokinetic and pharmacodynamic similarity of biosimilar natalizumab (PB006) to its reference medicine: a randomized controlled trial

Author:

Wessels Hendrik1,von Richter Oliver2,Velinova Maria3,Höfler Josef4,Chamberlain Paul5,Kromminga Arno6,Lehnick Dirk7,Roth Karsten1

Affiliation:

1. Polpharma Biologics S.A, Gdansk, Poland

2. Hexal AG (A Sandoz company), Holzkirchen, Germany

3. Early Development Services, ICON, Groningen, The Netherlands

4. Staburo GmbH, Munich, Germany

5. bioLOGICA Consulting, Arthez d’Asson, France

6. Kromminga Consulting, Hamburg, Germany

7. Faculty of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland

Funder

Polpharma Biologics S.A

Publisher

Informa UK Limited

Subject

Clinical Biochemistry,Drug Discovery,Pharmacology

Reference34 articles.

1. Biogen Netherlands B.V. Tysabri® (natalizumab). Summary of Product Characteristics 2022. [Internet]. [cited 2023 Apr 6]. Available from: https://www.ema.europa.eu/documents/product-information/tysabri-epar-product-information_en.pdf.

2. Biogen Inc. Tysabri® (natalizumab). Prescribing Information. [Internet]. 2023 [cited 2023 Oct 2]. Available from: https://www.tysabri.com/content/dam/commercial/tysabri/pat/en_us/pdf/tysabri_prescribing_information.pdf

3. The Role of Alpha-4 Integrin in the Aetiology of Multiple Sclerosis

4. Natalizumab and Impedance of the Homing of CD34+ Hematopoietic Progenitors

5. Natalizumab exerts a suppressive effect on surrogates of B cell function in blood and CSF

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