321 related articles for article (PubMed ID: 29027130)
1. Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use.
Cilia M; Ruiz S; Richardson P; Salmonson T; Serracino-Inglott A; Wirth F; Borg JJ
AAPS PharmSciTech; 2018 Feb; 19(2):489-511. PubMed ID: 29027130
[TBL] [Abstract][Full Text] [Related]
2. Where is industry getting it wrong? A review of quality concerns raised at Day 120 by the Committee For Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products.
Borg JJ; Robert JL; Wade G; Aislaitner G; Pirozynski M; Abadie E; Salmonson T; Vella Bonanno P
J Pharm Pharm Sci; 2009; 12(2):181-98. PubMed ID: 19732496
[TBL] [Abstract][Full Text] [Related]
3. 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]
4. PDA Biosimilars Workshop Report (September 27-28, 2018)-Getting It Right the First Time for Biosimilar Marketing Applications.
Krause S; Lacana E; Welch J; Shapiro M; Downey C; Chung J; Zhou Q; Van Der Plas M; Depatie C; Ingram B; Srebalus-Barnes C; Polozova A; Rellahan B; Choi D; Burdick R; Stangler T; Shacter E
PDA J Pharm Sci Technol; 2019; 73(4):401-416. PubMed ID: 31004040
[TBL] [Abstract][Full Text] [Related]
5. Pharmaceutical issues during the review of European Marketing Authorisation Applications in Malta
Chetcuti M; Serracino-Inglott A; Flores G; Borg JJ
Pharm Dev Technol; 2018 Jul; 23(6):561-572. PubMed ID: 28758819
[TBL] [Abstract][Full Text] [Related]
6. Marketing authorisation applications submitted to the European Medicines Agency by small and medium-sized enterprises: an analysis of major objections and their impact on outcomes.
Amaouche N; Casaert Salomé H; Collignon O; Santos MR; Ziogas C
Drug Discov Today; 2018 Oct; 23(10):1801-1805. PubMed ID: 29953957
[TBL] [Abstract][Full Text] [Related]
7. The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.
Kroes BH
J Ethnopharmacol; 2014 Dec; 158 Pt B():449-53. PubMed ID: 25086408
[TBL] [Abstract][Full Text] [Related]
8. [Biosimilars, the journey has begun].
Martos-Rosa A; Martínez-de la Plata JE; Morales-Molina JA; Fayet-Pérez A; Acosta-Robles PJ
Farm Hosp; 2015 Mar; 39(2):114-7. PubMed ID: 25817091
[TBL] [Abstract][Full Text] [Related]
9. 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]
10. Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
Kirsch-Stefan N; Guillen E; Ekman N; Barry S; Knippel V; Killalea S; Weise M; Wolff-Holz E
BioDrugs; 2023 Nov; 37(6):855-871. PubMed ID: 37831324
[TBL] [Abstract][Full Text] [Related]
11. [Biosimilars].
Krämer I
Ther Umsch; 2011 Nov; 68(11):659-66. PubMed ID: 22045529
[TBL] [Abstract][Full Text] [Related]
12. European regulatory use and impact of subgroup evaluation in marketing authorisation applications.
Tanniou J; Teerenstra S; Hassan S; Elferink A; van der Tweel I; Gispen-de Wied C; Roes KCB
Drug Discov Today; 2017 Dec; 22(12):1760-1764. PubMed ID: 28943304
[TBL] [Abstract][Full Text] [Related]
13. 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]
14. The Small- and Medium-sized Enterprises Office (SME Office) at the European Medicines Agency.
Carr M
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2010 Jan; 53(1):20-3. PubMed ID: 20101799
[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. Granting marketing authorisation for medicines in South East European countries: the point of view of the authority.
Tomić S; Sucić AF; Martinac AI
Regul Toxicol Pharmacol; 2010; 57(2-3):325-32. PubMed ID: 20385190
[TBL] [Abstract][Full Text] [Related]
17. The regulatory framework of biosimilars in the European Union.
Minghetti P; Rocco P; Cilurzo F; Vecchio LD; Locatelli F
Drug Discov Today; 2012 Jan; 17(1-2):63-70. PubMed ID: 21856438
[TBL] [Abstract][Full Text] [Related]
18. Reflections on Decisions Made on the Well-Established Use of Medicinal Products by EU Regulators and the ECJ.
Borg JJ; Laslop A; Pani L; Maciulaitis R; Melchiorri D
Sci Pharm; 2014; 82(3):541-54. PubMed ID: 25853067
[TBL] [Abstract][Full Text] [Related]
19. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products in Europe.
Schuessler-Lenz M; Herberts C; Reischl I; Ruiz S; Celis P; Beuneu C; Kjeken R; Timón M
Adv Exp Med Biol; 2023; 1430():1-21. PubMed ID: 37526839
[TBL] [Abstract][Full Text] [Related]
20. 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]
[Next] [New Search]
