BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

258 related articles for article (PubMed ID: 31933180)

  • 1. Regulatory Perspective of International Agencies for Development of Biosimilar Products (Monoclonal Antibodies): An Overview.
    Sharma A; Khante S; Mahadik KR; Gaikwad VL
    Ther Innov Regul Sci; 2020 Sep; 54(5):965-977. PubMed ID: 31933180
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation.
    Scott BJ; Klein AV; Wang J
    J Clin Pharmacol; 2015 Mar; 55 Suppl 3():S123-32. PubMed ID: 24965228
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Biosimilar monoclonal antibodies: the scientific basis for extrapolation.
    Schellekens H; Lietzan E; Faccin F; Venema J
    Expert Opin Biol Ther; 2015; 15(11):1633-46. PubMed ID: 26365396
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Progress in biosimilar monoclonal antibody development: the infliximab biosimilar CT-P13 in the treatment of rheumatic diseases.
    Braun J; Kudrin A
    Immunotherapy; 2015; 7(2):73-87. PubMed ID: 25713985
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Biosimilar Drugs for Multiple Sclerosis: An Unmet International Need or a Regulatory Risk?
    Rivera VM
    Neurol Ther; 2019 Dec; 8(2):177-184. PubMed ID: 31313222
    [TBL] [Abstract][Full Text] [Related]  

  • 6. 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]  

  • 7. Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry.
    Beck A; Reichert JM
    MAbs; 2013; 5(5):621-3. PubMed ID: 23924791
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Current Japanese Regulatory Systems for Generics and Biosimilars.
    Kuribayashi R; Sawanobori K
    J Pharm Sci; 2018 Mar; 107(3):785-787. PubMed ID: 29113922
    [TBL] [Abstract][Full Text] [Related]  

  • 9. [The story of biosimilars--chance or threat?].
    Woroń J; Kocić I
    Pol Merkur Lekarski; 2014 Nov; 37(221):311-5. PubMed ID: 25546996
    [TBL] [Abstract][Full Text] [Related]  

  • 10. 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]  

  • 11. Japanese regulation of biosimilar products: past experience and current challenges.
    Arato T
    Br J Clin Pharmacol; 2016 Jul; 82(1):30-40. PubMed ID: 26987746
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Regulatory considerations in oncologic biosimilar drug development.
    Macdonald JC; Hartman H; Jacobs IA
    MAbs; 2015; 7(4):653-61. PubMed ID: 25961747
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Ten years of biosimilars in Europe: development and evolution of the regulatory pathways.
    Schiestl M; Zabransky M; Sörgel F
    Drug Des Devel Ther; 2017; 11():1509-1515. PubMed ID: 28553082
    [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. 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]  

  • 16. 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]  

  • 17. 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]  

  • 18. Monoclonal antibody: the corner stone of modern biotherapeutics.
    Xia ZN; Cai XT; Cao P
    Yao Xue Xue Bao; 2012 Oct; 47(10):1275-80. PubMed ID: 23289138
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Extrapolation and Interchangeability of Infliximab and Adalimumab in Inflammatory Bowel Disease.
    Chang S; Hanauer S
    Curr Treat Options Gastroenterol; 2017 Mar; 15(1):53-70. PubMed ID: 28164249
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Biosimilar Monoclonal Antibodies for Inflammatory Bowel Disease: Current Comfort and Future Prospects.
    Gecse KB; Lakatos PL
    Drugs; 2016 Oct; 76(15):1413-1420. PubMed ID: 27638739
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 13.