Real-world observational cohort study of treatment patterns and safety outcomes of infliximab biosimilar CT-P13 for the treatment of inflammatory bowel disease (CONNECT-IBD)

Author:

Bokemeyer Bernd1ORCID,Hlavaty Tibor2,Allez Matthieu3ORCID,Selema Pamela4,Moosavi Shahrzad4,Cadatal Mary Jane5,Fowler Heather6,Mueller Markus7,Liau Katherine F8,Gisbert Javier P9ORCID

Affiliation:

1. Interdisciplinary Crohn Colitis Centre Minden, Minden, Germany

2. 5th Department of Internal Medicine, Sub-department of Gastroenterology and Hepatology, University Hospital Bratislava and Comenius University, Bratislava, Slovakia

3. Gastroenterology Department, Hôpital Saint-Louis - APHP, INSERM U1160, Université De Paris, Paris, France

4. Worldwide Safety and Risk Management, Pfizer, Inc, New York City, NY, USA

5. Global Biometrics and Data Management, Pfizer, Inc, Manila, Philippines

6. Clinical Development and Operations, Pfizer, Inc, London, UK

7. Medical Affairs, Pfizer, Pharma GmbH, Berlin, Germany

8. Biosimilars, Pfizer, Inc, La Jolla, CA, USA

9. Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain

Funder

Hospira, Inc., which was acquired by Pfizer, Inc., in September 2015

Publisher

Informa UK Limited

Subject

Clinical Biochemistry,Drug Discovery,Pharmacology

Reference31 articles.

1. Inflammatory bowel disease: clinical aspects and treatments

2. Biologic therapies in inflammatory bowel disease

3.

Remicade® (infliximab): 20 years of contributions to science and medicine

4. US Food and Drug Administration (FDA). Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry; 2015 [cited 2020 15 Feb]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf

5. US Food and Drug Administration (FDA). Patient materials, biosimilars; 2019 [cited 2020 5 Mar]. Available from: https://www.fda.gov/drugs/biosimilars/patient-materials

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