274 related articles for article (PubMed ID: 21861538)
1. Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations.
Dranitsaris G; Amir E; Dorward K
Drugs; 2011 Aug; 71(12):1527-36. PubMed ID: 21861538
[TBL] [Abstract][Full Text] [Related]
2. Biosimilars: policy, clinical, and regulatory considerations.
Gottlieb S
Am J Health Syst Pharm; 2008 Jul; 65(14 Suppl 6):S2-8. PubMed ID: 18591712
[TBL] [Abstract][Full Text] [Related]
3. A Comprehensive Overview on Biosimilars.
Kadam V; Bagde S; Karpe M; Kadam V
Curr Protein Pept Sci; 2016; 17(8):756-761. PubMed ID: 26916165
[TBL] [Abstract][Full Text] [Related]
4. Clinical trial design in biosimilar drug development.
Dranitsaris G; Dorward K; Hatzimichael E; Amir E
Invest New Drugs; 2013 Apr; 31(2):479-87. PubMed ID: 23161336
[TBL] [Abstract][Full Text] [Related]
5. Biosimilars: where we were and where we are.
Challand R; Gorham H; Constant J
J Biopharm Stat; 2014; 24(6):1154-64. PubMed ID: 25036475
[TBL] [Abstract][Full Text] [Related]
6. Biosimilar monoclonal antibodies: preclinical and clinical development aspects.
Gonçalves J; Araújo F; Cutolo M; Fonseca JE
Clin Exp Rheumatol; 2016; 34(4):698-705. PubMed ID: 27383278
[TBL] [Abstract][Full Text] [Related]
7. Biosimilar safety considerations in clinical practice.
Choy E; Jacobs IA
Semin Oncol; 2014 Feb; 41 Suppl 1():S3-14. PubMed ID: 24560025
[TBL] [Abstract][Full Text] [Related]
8. Interchangeability Of Biological Drug Products-FDA Draft Guidance.
Endrenyi L; Markus R
J Biopharm Stat; 2019; 29(6):1003-1010. PubMed ID: 31023141
[TBL] [Abstract][Full Text] [Related]
9. Biopharmaceuticals and biosimilars in psoriasis: what the dermatologist needs to know.
Strober BE; Armour K; Romiti R; Smith C; Tebbey PW; Menter A; Leonardi C
J Am Acad Dermatol; 2012 Feb; 66(2):317-22. PubMed ID: 22243723
[TBL] [Abstract][Full Text] [Related]
10. Biosimilars: current scientific and regulatory considerations.
Chugh PK; Roy V
Curr Clin Pharmacol; 2014 Feb; 9(1):53-63. PubMed ID: 23952143
[TBL] [Abstract][Full Text] [Related]
11. [Biosimilars : Current state of the build up to series production].
Aringer M; Dörner T
Z Rheumatol; 2013 Nov; 72(9):873-7. PubMed ID: 23934050
[TBL] [Abstract][Full Text] [Related]
12. From bioequivalence to biosimilars: How much do regulators dare?
Weise M
Z Evid Fortbild Qual Gesundhwes; 2019 Mar; 140():58-62. PubMed ID: 30622000
[TBL] [Abstract][Full Text] [Related]
13. The challenge of biosimilars.
Mellstedt H; Niederwieser D; Ludwig H
Ann Oncol; 2008 Mar; 19(3):411-9. PubMed ID: 17872902
[TBL] [Abstract][Full Text] [Related]
14. What are biosimilars and are they important?
Drug Ther Bull; 2013 May; 51(5):57-60. PubMed ID: 23657197
[TBL] [Abstract][Full Text] [Related]
15. Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective.
Kurki P; Barry S; Bourges I; Tsantili P; Wolff-Holz E
Drugs; 2021 Nov; 81(16):1881-1896. PubMed ID: 34596876
[TBL] [Abstract][Full Text] [Related]
16. Biosimilars in Dermatology: Current Situation (Part I).
Puig L; Carretero G; Daudén E; Ferrándiz C; Marrón SE; Martorell A; Pérez-Suárez B; Rodriguez-Cerdeira C; Ruiz-Villaverde R; Sánchez-Carazo JL; Velasco M;
Actas Dermosifiliogr; 2015 Sep; 106(7):545-9. PubMed ID: 25987472
[TBL] [Abstract][Full Text] [Related]
17. On safety margin for drug interchangeability.
Zheng J; Chow SC; Song F
J Biopharm Stat; 2017; 27(2):293-307. PubMed ID: 27911675
[TBL] [Abstract][Full Text] [Related]
18. Why an abbreviated FDA pathway for biosimilars is overhyped.
Miller HI
Nat Biotechnol; 2011 Sep; 29(9):794-5. PubMed ID: 21904318
[No Abstract] [Full Text] [Related]
19. 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]
20. Understanding biosimilars and its regulatory aspects across the globe: an ophthalmology perspective.
Sharma A; Kumar N; Kuppermann BD; Bandello F; Loewenstein A
Br J Ophthalmol; 2020 Jan; 104(1):2-7. PubMed ID: 31315829
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]