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]