We have located links that may give you full text access.
Journal Article
Review
A Critical Review of Biosimilars in IBD: The Confluence of Biologic Drug Development, Regulatory Requirements, Clinical Outcomes, and Big Business.
Inflammatory Bowel Diseases 2016 October
On February 9, 2016, the Food and Drug Administration Arthritis Advisory Committee recommended by a vote of 21 to 3, that the biosimilar to infliximab, CT-P13, be approved for rheumatoid arthritis and ankylosing spondylitis and, by extrapolation, for all the indications for which infliximab is currently approved, including adult and pediatric ulcerative colitis and Crohn's disease. On April 5, 2016, the Food and Drug Administration concurred with this recommendation and approved CT-P13 (Inflectra; Pfizer Inc.) for all diseases for which infliximab had previously been approved, including adult and pediatric moderate to severe ulcerative colitis and pediatric and adult moderate to severe and fistulizing Crohn's disease. This was despite the absence of any randomized controlled trials studying the infliximab biosimilar in any inflammatory bowel disease. This highly controversial approach has been criticized by various rheumatology and gastroenterology professional societies around the world. This review will cover the stepwise approach to biosimilar development, issues of extrapolation and interchangeability, and conclude with a discussion of the regulatory, intellectual property issues, and financial implications, which will all intersect in the decision and ability to prescribe a biosimilar or reference anti-tumor necrosis factor drug.
Full text links
Related Resources
Trending Papers
A Guide to the Use of Vasopressors and Inotropes for Patients in Shock.Journal of Intensive Care Medicine 2024 April 14
Prevention and treatment of ischaemic and haemorrhagic stroke in people with diabetes mellitus: a focus on glucose control and comorbidities.Diabetologia 2024 April 17
British Society for Rheumatology guideline on management of adult and juvenile onset Sjögren disease.Rheumatology 2024 April 17
Diagnosis and Management of Cardiac Sarcoidosis: A Scientific Statement From the American Heart Association.Circulation 2024 April 19
Albumin: a comprehensive review and practical guideline for clinical use.European Journal of Clinical Pharmacology 2024 April 13
Eosinophilic Esophagitis: Clinical Pearls for Primary Care Providers and Gastroenterologists.Mayo Clinic Proceedings 2024 April
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app