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.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

323 related articles for article (PubMed ID: 21441787)

  • 1. Worldwide experience with biosimilar development.
    McCamish M; Woollett G
    MAbs; 2011; 3(2):209-17. PubMed ID: 21441787
    [TBL] [Abstract][Full Text] [Related]  

  • 2. [The Polish Task Force position statement on safety of biologic treatment with monoclonal antibodies and soluble receptors].
    Jahnz-Rozyk K; Wiesik-Szewczyk E;
    Pol Merkur Lekarski; 2014 Jul; 37(217):5-9. PubMed ID: 25154192
    [TBL] [Abstract][Full Text] [Related]  

  • 3. [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]  

  • 4. Biosimilar drugs : concerns and opportunities.
    Genazzani AA; Biggio G; Caputi AP; Del Tacca M; Drago F; Fantozzi R; Canonico PL
    BioDrugs; 2007; 21(6):351-6. PubMed ID: 18020619
    [TBL] [Abstract][Full Text] [Related]  

  • 5. 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]  

  • 6. Biosimilars: the need, the challenge, the future: the FDA perspective.
    Epstein MS; Ehrenpreis ED; Kulkarni PM;
    Am J Gastroenterol; 2014 Dec; 109(12):1856-9. PubMed ID: 24957160
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges.
    Chapman K; Adjei A; Baldrick P; da Silva A; De Smet K; DiCicco R; Hong SS; Jones D; Leach MW; McBlane J; Ragan I; Reddy P; Stewart DI; Suitters A; Sims J
    MAbs; 2016; 8(3):427-35. PubMed ID: 26854177
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Development and regulation of biosimilars: current status and future challenges.
    Tsiftsoglou AS; Ruiz S; Schneider CK
    BioDrugs; 2013 Jun; 27(3):203-11. PubMed ID: 23553340
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price!
    Dutta B; Huys I; Vulto AG; Simoens S
    BioDrugs; 2020 Apr; 34(2):159-170. PubMed ID: 31792843
    [TBL] [Abstract][Full Text] [Related]  

  • 10. 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]  

  • 11. 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]  

  • 12. Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States.
    Ahmed I; Kaspar B; Sharma U
    Clin Ther; 2012 Feb; 34(2):400-19. PubMed ID: 22244050
    [TBL] [Abstract][Full Text] [Related]  

  • 13. The US approach to biosimilars: the long-awaited FDA approval pathway.
    Calvo B; Zuñiga L
    BioDrugs; 2012 Dec; 26(6):357-61. PubMed ID: 23030677
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Optimizing use and addressing challenges to uptake of biosimilars.
    Leber MB
    Am J Manag Care; 2018 Nov; 24(21 Suppl):S457-S461. PubMed ID: 30452214
    [TBL] [Abstract][Full Text] [Related]  

  • 15. 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]  

  • 16. 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]  

  • 17. Biosimilars: The US Regulatory Framework.
    Christl LA; Woodcock J; Kozlowski S
    Annu Rev Med; 2017 Jan; 68():243-254. PubMed ID: 27813877
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Biosimilars: biologics that meet patients' needs and healthcare economics.
    McCamish M; Yoon W; McKay J
    Am J Manag Care; 2016 Sep; 22(13 Suppl):S439-S442. PubMed ID: 28719221
    [TBL] [Abstract][Full Text] [Related]  

  • 19. 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]  

  • 20.
    ; ; . PubMed ID:
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 17.