Methodologic considerations for noninterventional studies of switching from reference biologic to biosimilars-Reference-Cited by-同舟云学术

Methodologic considerations for noninterventional studies of switching from reference biologic to biosimilars

Published:2019-07-12 Issue:7 Volume:29 Page:757-769
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Desai Rishi J.¹^ORCID,Kim Seoyoung C.¹,Curtis Jeffrey R.²,Bosco Jaclyn L.F.³,Eichelberger Bernadette⁴,Barr Charles E.⁴,Lockhart Catherine M.⁴,Bradbury Brian D.⁵,Clewell Jerry⁶,Cohen Hillel P.⁷,Gagne Joshua J.¹,

Affiliation:

1. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston Massachusetts

2. Division of Immunology and Rheumatology University of Alabama at Birmingham Birmingham Alabama

3. Real‐World Evidence Solutions IQVIA™ Cambridge Massachusetts

4. Biologics and Biosimilars Collective Intelligence Consortium Alexandria Virginia

5. Center for Observational Research Amgen, Inc. Thousand Oaks California

6. Abbvie North Chicago Illinois

7. Sandoz Inc Princeton New Jersey

Funder

Biologics and Biosimilars Collective Intelligence Consortium

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.4809

Reference64 articles.

1. Biosimilar and Interchangeable Products. Food and Drug Administration. Available athttps://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm#top. Accessed on 2‐19‐2018.

2. Guideline on similar biological medicinal products. European Medicines Agency.2014. Available athttps://www.ema.europa.eu/documents/scientific‐guideline/guideline‐similar‐biological‐medicinal‐products‐rev1_en.pdf accessed 1‐1‐2018.

3. Biologics Price Competition and Innovation Act of 2009. 42 U.S.C. § 262(k).

4. Considerations in Demonstrating Interchangeability With a Reference Product: Guidance for Industry‐ Draft Guidance.Center for Biologics Evaluation and Research (CBER).2017.

5. Interchangeability of Biosimilars: A European Perspective

Cited by 8 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Uptake of tumour necrosis factor-alpha inhibitor biosimilars for psoriasis: a drug utilization study from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR);British Journal of Dermatology;2023-04-05

2. Discontinuation of infliximab treatment in patients with inflammatory bowel disease who retransitioned to originator and those who remained on biosimilar;Therapeutic Advances in Gastroenterology;2023-01

3. The US Food and Drug Administration Sentinel System: a national resource for a learning health system;Journal of the American Medical Informatics Association;2022-09-12

4. Impact of Infliximab-dyyb (Infliximab Biosimilar) on Clinical and Patient-Reported Outcomes: 1-Year Follow-up Results from an Observational Real-World Study Among Patients with Inflammatory Bowel Disease in the US and Canada (the ONWARD Study);Advances in Therapy;2022-03-16

5. Flares after hydroxychloroquine reduction or discontinuation: results from the Systemic Lupus International Collaborating Clinics (SLICC) inception cohort;Annals of the Rheumatic Diseases;2021-12-15