Relative bioavailability, immunogenicity, and safety of two adalimumab-adbm formulations in healthy volunteers: a double-blind, randomized, single-dose, parallel-arm Phase I trial (VOLTAIRE-HCLF)-Reference-Cited by-同舟云学术

Relative bioavailability, immunogenicity, and safety of two adalimumab-adbm formulations in healthy volunteers: a double-blind, randomized, single-dose, parallel-arm Phase I trial (VOLTAIRE-HCLF)

Published:2024-05-19 Issue:7 Volume:24 Page:673-679
ISSN:1471-2598
Container-title:Expert Opinion on Biological Therapy
language:en
Short-container-title:Expert Opinion on Biological Therapy

Author:

Moschetti Viktoria¹,Buschke Susanne²,Bertulis Julia²,Hohl Kathrin²,McCabe Dorothy³

Affiliation:

1. Global Clinical Development & Operations, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany

2. Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riss, Germany

3. Specialty Medicine, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA

Funder

Boehringer Ingelheim

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/14712598.2024.2354902

Reference8 articles.

1. Boehringer Ingelheim Pharmaceuticals I. Cyltezo; [package insert] 2023 [cited 2023 Sep 18]. Available from: https://content.boehringer-ingelheim.com/DAM/9d0e3bae-9a17-4979-91bc-af1e011eeb8a/cyltezo-us-pi.pdf

2. U.S. FDA. FDA approves cyltezo the first interchangeable biosimilar to humira 2021. [cited 2023 Sep 19]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-cyltezo-first-interchangeable-biosimilar-humira

4. Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn's disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial