310 related articles for article (PubMed ID: 25912826)
1. The similarity question for biologicals and non-biological complex drugs.
Crommelin DJ; Shah VP; Klebovich I; McNeil SE; Weinstein V; Flühmann B; Mühlebach S; de Vlieger JS
Eur J Pharm Sci; 2015 Aug; 76():10-7. PubMed ID: 25912826
[TBL] [Abstract][Full Text] [Related]
2. The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations.
Klein K; Stolk P; De Bruin ML; Leufkens HGM; Crommelin DJA; De Vlieger JSB
Eur J Pharm Sci; 2019 May; 133():228-235. PubMed ID: 30953753
[TBL] [Abstract][Full Text] [Related]
3. 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]
4. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks.
Hussaarts L; Mühlebach S; Shah VP; McNeil S; Borchard G; Flühmann B; Weinstein V; Neervannan S; Griffiths E; Jiang W; Wolff-Holz E; Crommelin DJA; de Vlieger JSB
Ann N Y Acad Sci; 2017 Nov; 1407(1):39-49. PubMed ID: 28445611
[TBL] [Abstract][Full Text] [Related]
5. Regulatory Science Approach in Pharmaceutical Development of Follow-on Versions of Non-Biological Complex Drug Products.
Zagalo DM; Simões S; Sousa J
J Pharm Sci; 2022 Oct; 111(10):2687-2713. PubMed ID: 35901943
[TBL] [Abstract][Full Text] [Related]
6. 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]
7. Scientific considerations for complex drugs in light of established and emerging regulatory guidance.
Holloway C; Mueller-Berghaus J; Lima BS; Lee SL; Wyatt JS; Nicholas JM; Crommelin DJ
Ann N Y Acad Sci; 2012 Dec; 1276():26-36. PubMed ID: 23193987
[TBL] [Abstract][Full Text] [Related]
8. How to select a nanosimilar.
Astier A; Barton Pai A; Bissig M; Crommelin DJA; Flühmann B; Hecq JD; Knoeff J; Lipp HP; Morell-Baladrón A; Mühlebach S
Ann N Y Acad Sci; 2017 Nov; 1407(1):50-62. PubMed ID: 28715605
[TBL] [Abstract][Full Text] [Related]
9. Biologicals and biosimilars: safety issues in Europe.
Portela MDCC; Sinogas C; Albuquerque de Almeida F; Baptista-Leite R; Castro-Caldas A
Expert Opin Biol Ther; 2017 Jul; 17(7):871-877. PubMed ID: 28540760
[TBL] [Abstract][Full Text] [Related]
10. [Biologics - nomenclature and classification].
Eichbaum C; Haefeli WE
Ther Umsch; 2011 Nov; 68(11):593-601. PubMed ID: 22045521
[TBL] [Abstract][Full Text] [Related]
11. Non-biological Complex Drugs (NBCDs): Complex Pharmaceuticals in Need of Individual Robust Clinical Assessment Before Any Therapeutic Equivalence Decision.
Gaspar RS; Silva-Lima B; Magro F; Alcobia A; da Costa FL; Feio J
Front Med (Lausanne); 2020; 7():590527. PubMed ID: 33330550
[TBL] [Abstract][Full Text] [Related]
12. Evaluation of Therapeutic Equivalence for the Follow-On Version of Intravenously Administered Non-Biological Complex Drugs.
Sun Z; Jiang J; Chen X
Clin Pharmacokinet; 2020 Aug; 59(8):995-1004. PubMed ID: 32328977
[TBL] [Abstract][Full Text] [Related]
13. [Evolution of biologicals in inflammation medicine--biosimilars in gastroenterology, rheumatology and dermatology].
Schreiber S; Luger T; Mittendorf T; Mrowietz U; Müller-Ladner U; Schröder J; Stallmach A; Bokemeyer B
Dtsch Med Wochenschr; 2014 Nov; 139(47):2399-404. PubMed ID: 25390629
[TBL] [Abstract][Full Text] [Related]
14. From Bioequivalence to Biosimilarity: The Rise of a Novel Regulatory Framework.
Karalis VD
Drug Res (Stuttg); 2016 Jan; 66(1):1-6. PubMed ID: 25894088
[TBL] [Abstract][Full Text] [Related]
15. The therapeutic equivalence of complex drugs.
Schellekens H; Klinger E; Mühlebach S; Brin JF; Storm G; Crommelin DJ
Regul Toxicol Pharmacol; 2011 Feb; 59(1):176-83. PubMed ID: 20951177
[TBL] [Abstract][Full Text] [Related]
16. How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider.
Schellekens H; Stegemann S; Weinstein V; de Vlieger JS; Flühmann B; Mühlebach S; Gaspar R; Shah VP; Crommelin DJ
AAPS J; 2014 Jan; 16(1):15-21. PubMed ID: 24065600
[TBL] [Abstract][Full Text] [Related]
17. Biosimilars entering the clinic without animal studies. A paradigm shift in the European Union.
van Aerts LA; De Smet K; Reichmann G; van der Laan JW; Schneider CK
MAbs; 2014; 6(5):1155-62. PubMed ID: 25517301
[TBL] [Abstract][Full Text] [Related]
18. Anti-tumor necrosis factor biosimilars and intended copies in rheumatology: Perspective from the Asia Pacific region.
Rath PD; Chen DY; Gu J; Lee VWY; Al Ani NA; Shirazy K; Llamado L
Int J Rheum Dis; 2019 Jan; 22(1):9-24. PubMed ID: 30338644
[TBL] [Abstract][Full Text] [Related]
19. Biosimilars: current status and future directions.
Roger SD
Expert Opin Biol Ther; 2010 Jul; 10(7):1011-8. PubMed ID: 20384525
[TBL] [Abstract][Full Text] [Related]
20. Regulatory considerations for generic products of non-biological complex drugs.
Liu YH; Chen YS; Tseng T; Jiang ML; Gau CS; Chang LC
J Food Drug Anal; 2023 Mar; 31(1):20-31. PubMed ID: 37224550
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
