These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
455 related articles for article (PubMed ID: 33455482)
1. Considerations related to comparative clinical studies for biosimilars. Rathore AS; Stevenson JG; Chhabra H Expert Opin Drug Saf; 2021 Mar; 20(3):265-274. PubMed ID: 33455482 [No Abstract] [Full Text] [Related]
2. A Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding? Hung A; Vu Q; Mostovoy L J Manag Care Spec Pharm; 2017 Dec; 23(12):1234-1244. PubMed ID: 29172975 [TBL] [Abstract][Full Text] [Related]
3. Explaining biosimilars and how reverse engineering plays a critical role in their development. Bellinvia S; Edwards CJ Expert Opin Drug Discov; 2020 Nov; 15(11):1283-1289. PubMed ID: 32717155 [TBL] [Abstract][Full Text] [Related]
4. Clinical trial development for biosimilars. Alten R; Cronstein BN Semin Arthritis Rheum; 2015 Jun; 44(6 Suppl):S2-8. PubMed ID: 26058550 [TBL] [Abstract][Full Text] [Related]
5. Biosimilars: A consideration of the regulations in the United States and European union. Daller J Regul Toxicol Pharmacol; 2016 Apr; 76():199-208. PubMed ID: 26732800 [TBL] [Abstract][Full Text] [Related]
6. Application of the FDA Biosimilar Extrapolation Framework to Make Off-Label Determinations. Li E; Lobaina E J Manag Care Spec Pharm; 2017 Dec; 23(12):1227-1232. PubMed ID: 29172978 [TBL] [Abstract][Full Text] [Related]
7. Regulation of biosimilar medicines and current perspectives on interchangeability and policy. O'Callaghan J; Barry SP; Bermingham M; Morris JM; Griffin BT Eur J Clin Pharmacol; 2019 Jan; 75(1):1-11. PubMed ID: 30187103 [TBL] [Abstract][Full Text] [Related]
8. Understanding the biosimilar approval and extrapolation process-A case study of an epoetin biosimilar. Agarwal AB; McBride A Crit Rev Oncol Hematol; 2016 Aug; 104():98-107. PubMed ID: 27317353 [TBL] [Abstract][Full Text] [Related]
9. Are biosimilars patentable? Rolfe D; Parker J; Morgan M Expert Opin Ther Pat; 2016 Aug; 26(8):871-5. PubMed ID: 27215647 [TBL] [Abstract][Full Text] [Related]
10. Biosimilars: Implications for health-system pharmacists. Lucio SD; Stevenson JG; Hoffman JM Am J Health Syst Pharm; 2013 Nov; 70(22):2004-17. PubMed ID: 24173009 [TBL] [Abstract][Full Text] [Related]
11. Considerations in the early development of biosimilar products. Li EC; Abbas R; Jacobs IA; Yin D Drug Discov Today; 2015 May; 20 Suppl 2():1-9. PubMed ID: 25572407 [TBL] [Abstract][Full Text] [Related]
13. Safety and Effectiveness of Anti-Tumor Necrosis Factor-Alpha Biosimilar Agents in the Treatment of Psoriasis. Reynolds KA; Pithadia DJ; Lee EB; Liao W; Wu JJ Am J Clin Dermatol; 2020 Aug; 21(4):483-491. PubMed ID: 32048187 [TBL] [Abstract][Full Text] [Related]
14. Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions. Bennett CL; Schoen MW; Hoque S; Witherspoon BJ; Aboulafia DM; Hwang CS; Ray P; Yarnold PR; Chen BK; Schooley B; Taylor MA; Wyatt MD; Hrushesky WJ; Yang YT Lancet Oncol; 2020 Dec; 21(12):e575-e588. PubMed ID: 33271114 [TBL] [Abstract][Full Text] [Related]
15. Epoetin alfa-epbx: a new entrant into a crowded market. a historical review of the role of erythropoietin stimulating agents and the development of the first epoetin biosimilar in the United States. Anand S; Al-Mondhiry J; Fischer K; Glaspy J Expert Rev Clin Pharmacol; 2021 Jan; 14(1):1-8. PubMed ID: 33307871 [No Abstract] [Full Text] [Related]
17. Biosimilars: How Can Payers Get Long-Term Savings? Mestre-Ferrandiz J; Towse A; Berdud M Pharmacoeconomics; 2016 Jun; 34(6):609-16. PubMed ID: 26792791 [TBL] [Abstract][Full Text] [Related]
18. [Opportunities and challenges of extrapolation for biosimilars]. Weise M; Wolff-Holz E Z Gastroenterol; 2016 Nov; 54(11):1211-1216. PubMed ID: 27711947 [TBL] [Abstract][Full Text] [Related]
19. [Evolution of biologicals in inflammation medicine--biosimilars in gastroenterology, rheumatology and dermatology]. Schreiber S; Luger T; Mittendorf T; Mrowietz U; Müller-Ladner U; Schröder J; Stallmach A; Bokemeyer B Dtsch Med Wochenschr; 2014 Nov; 139(47):2399-404. PubMed ID: 25390629 [TBL] [Abstract][Full Text] [Related]
20. Are biosimilars approved for use in psoriasis safe enough to replace leading biologic therapies? A review. Reynolds KA; Pithadia DJ; Lee EB; Han G; Wu JJ Expert Opin Drug Saf; 2020 Apr; 19(4):459-466. PubMed ID: 32116071 [No Abstract] [Full Text] [Related] [Next] [New Search]