398 related articles for article (PubMed ID: 31897530)
1. Clinical evidence supporting the marketing authorization of biosimilars in Europe.
Allocati E; Bertele' V; Gerardi C; Garattini S; Banzi R
Eur J Clin Pharmacol; 2020 Apr; 76(4):557-566. PubMed ID: 31897530
[TBL] [Abstract][Full Text] [Related]
2. Clinical trials for authorized biosimilars in the European Union: a systematic review.
Mielke J; Jilma B; Koenig F; Jones B
Br J Clin Pharmacol; 2016 Dec; 82(6):1444-1457. PubMed ID: 27580073
[TBL] [Abstract][Full Text] [Related]
3. Biosimilars in IBD: from theory to practice.
Danese S; Bonovas S; Peyrin-Biroulet L
Nat Rev Gastroenterol Hepatol; 2017 Jan; 14(1):22-31. PubMed ID: 27729659
[TBL] [Abstract][Full Text] [Related]
4. 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]
5. Biosimilar safety factors in clinical practice.
Reinisch W; Smolen J
Semin Arthritis Rheum; 2015 Jun; 44(6 Suppl):S9-15. PubMed ID: 26058551
[TBL] [Abstract][Full Text] [Related]
6. Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch.
Sagi S; Anjaneya P; Kalsekar S; Kottke A; Cohen HP
Drug Saf; 2023 Dec; 46(12):1391-1404. PubMed ID: 37902937
[TBL] [Abstract][Full Text] [Related]
7. [Biosimilars versus original biologics. Similarities and differences from development to approval].
Windisch J
Z Rheumatol; 2015 Oct; 74(8):672-81. PubMed ID: 26323591
[TBL] [Abstract][Full Text] [Related]
8. 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]
9. 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]
10. Biosimilar regulation in the EU.
Kurki P; Ekman N
Expert Rev Clin Pharmacol; 2015; 8(5):649-59. PubMed ID: 26294076
[TBL] [Abstract][Full Text] [Related]
11. Evolution of the EU Biosimilar Framework: Past and Future.
Wolff-Holz E; Tiitso K; Vleminckx C; Weise M
BioDrugs; 2019 Dec; 33(6):621-634. PubMed ID: 31541400
[TBL] [Abstract][Full Text] [Related]
12. Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction.
Ingrasciotta Y; Cutroneo PM; Marcianò I; Giezen T; Atzeni F; Trifirò G
Drug Saf; 2018 Nov; 41(11):1013-1022. PubMed ID: 29796832
[TBL] [Abstract][Full Text] [Related]
13. Strengths, weaknesses and future challenges of biosimilars' development. An opinion on how to improve the knowledge and use of biosimilars in clinical practice.
Scavone C; Rafaniello C; Berrino L; Rossi F; Capuano A
Pharmacol Res; 2017 Dec; 126():138-142. PubMed ID: 29113760
[TBL] [Abstract][Full Text] [Related]
14. An update on the clinical evidence that supports biosimilar approvals in Europe.
Mielke J; Jilma B; Jones B; Koenig F
Br J Clin Pharmacol; 2018 Jul; 84(7):1415-1431. PubMed ID: 29575017
[TBL] [Abstract][Full Text] [Related]
15. [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]
16. [Biosimilars].
Krämer I
Ther Umsch; 2011 Nov; 68(11):659-66. PubMed ID: 22045529
[TBL] [Abstract][Full Text] [Related]
17. [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]
18. Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases.
Rinaudo-Gaujous M; Paul S; Tedesco ED; Genin C; Roblin X; Peyrin-Biroulet L
Aliment Pharmacol Ther; 2013 Oct; 38(8):914-24. PubMed ID: 24001128
[TBL] [Abstract][Full Text] [Related]
19. [Regulatory aspects of biosimilars. Myths and facts].
Schneider CK; Weise M
Z Rheumatol; 2015 Oct; 74(8):695-700. PubMed ID: 26385104
[TBL] [Abstract][Full Text] [Related]
20. Challenges in the implementation of trastuzumab biosimilars: an expert panel's recommendations.
Pivot X; Aulagner G; Blay JY; Fumoleau P; Kaliski A; Sarkozy F; Limat S
Anticancer Drugs; 2015 Nov; 26(10):1009-16. PubMed ID: 26352219
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]