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Items: 1 to 20 of 112

1.

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. doi: 10.1111/j.1749-6632.2012.06811.x. Epub 2012 Nov 29.

PMID:
23193987
2.

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 30;76:10-7. doi: 10.1016/j.ejps.2015.04.010. Epub 2015 Apr 23.

3.

Biosimilars: policy, clinical, and regulatory considerations.

Gottlieb S.

Am J Health Syst Pharm. 2008 Jul 15;65(14 Suppl 6):S2-8. doi: 10.2146/ajhp080210.

PMID:
18591712
4.

NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives.

Zelenetz AD, Ahmed I, Braud EL, Cross JD, Davenport-Ennis N, Dickinson BD, Goldberg SE, Gottlieb S, Johnson PE, Lyman GH, Markus R, Matulonis UA, Reinke D, Li EC, DeMartino J, Larsen JK, Hoffman JM.

J Natl Compr Canc Netw. 2011 Sep;9 Suppl 4:S1-22.

PMID:
21976013
5.

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. doi: 10.1016/j.drudis.2011.08.001. Epub 2011 Aug 12. Review.

PMID:
21856438
6.

Biosimilar safety considerations in clinical practice.

Choy E, Jacobs IA.

Semin Oncol. 2014 Feb;41 Suppl 1:S3-14. doi: 10.1053/j.seminoncol.2013.12.001. Epub 2013 Dec 6.

PMID:
24560025
7.

Global regulatory standards for the approval of biosimilars.

Mounho B, Phillips A, Holcombe K, Grampp G, Lubiniecki T, Mollerup I, Jones C.

Food Drug Law J. 2010;65(4):819-37, ii-iii.

PMID:
24479248
8.

Biosimilars: what clinicians should know.

Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, Gravanis I, Heim HK, Heinonen E, Ho K, Moreau A, Narayanan G, Kruse NA, Reichmann G, Thorpe R, van Aerts L, Vleminckx C, Wadhwa M, Schneider CK.

Blood. 2012 Dec 20;120(26):5111-7. doi: 10.1182/blood-2012-04-425744. Epub 2012 Oct 23. Review.

9.

[Regulatory aspects of biosimilars. Myths and facts].

Schneider CK, Weise M.

Z Rheumatol. 2015 Oct;74(8):695-700. doi: 10.1007/s00393-014-1489-6. German.

PMID:
26385104
10.

Clinical trial design in biosimilar drug development.

Dranitsaris G, Dorward K, Hatzimichael E, Amir E.

Invest New Drugs. 2013 Apr;31(2):479-87. doi: 10.1007/s10637-012-9899-2. Epub 2012 Nov 17. Review.

PMID:
23161336
11.

Regulatory and clinical considerations for biosimilar oncology drugs.

Bennett CL, Chen B, Hermanson T, Wyatt MD, Schulz RM, Georgantopoulos P, Kessler S, Raisch DW, Qureshi ZP, Lu ZK, Love BL, Noxon V, Bobolts L, Armitage M, Bian J, Ray P, Ablin RJ, Hrushesky WJ, Macdougall IC, Sartor O, Armitage JO.

Lancet Oncol. 2014 Dec;15(13):e594-605. doi: 10.1016/S1470-2045(14)70365-1. Epub 2014 Nov 24. Review.

12.

Effective pharmaceutical regulation needs alignment with doctors.

Ebbers HC, Pieters T, Leufkens HG, Schellekens H.

Drug Discov Today. 2012 Feb;17(3-4):100-3. doi: 10.1016/j.drudis.2011.09.018. Epub 2011 Oct 6.

PMID:
22001600
13.

Comparability and biosimilarity: considerations for the healthcare provider.

Lee JF, Litten JB, Grampp G.

Curr Med Res Opin. 2012 Jun;28(6):1053-8. doi: 10.1185/03007995.2012.686902. Epub 2012 Jun 6. Review.

PMID:
22519391
14.

Developing clinical trials for biosimilars.

Bui LA, Taylor C.

Semin Oncol. 2014 Feb;41 Suppl 1:S15-25. doi: 10.1053/j.seminoncol.2013.12.002. Epub 2013 Dec 7. Review.

PMID:
24560024
15.

Health Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa, Canada, 14 May 2012.

Kay J, Feagan BG, Guirguis MS, Keystone EC, Klein AV, Lubiniecki AS, Mould DR, Nyarko KA, Ridgway AA, Trudeau ME, Wang J.

Biologicals. 2012 Nov;40(6):517-27. doi: 10.1016/j.biologicals.2012.09.010. Epub 2012 Oct 17.

16.

Current regulatory and scientific considerations for approving biosimilars in Iran.

Hadavand N, Valadkhani M, Zarbakhsh A.

Biologicals. 2011 Sep;39(5):325-7. doi: 10.1016/j.biologicals.2011.06.019. Epub 2011 Aug 27. Review.

17.

Scientific considerations for assessing biosimilar products.

Chow SC, Wang J, Endrenyi L, Lachenbruch PA.

Stat Med. 2013 Feb 10;32(3):370-81. doi: 10.1002/sim.5571. Epub 2012 Aug 30.

PMID:
22933240
18.

Statistical assessment of biosimilar products.

Chow SC, Liu JP.

J Biopharm Stat. 2010 Jan;20(1):10-30. doi: 10.1080/10543400903280266. Review.

PMID:
20077246
19.

Biosimilars in psoriasis: what can we expect?

Radtke MA, Augustin M.

J Dtsch Dermatol Ges. 2014 Apr;12(4):306-12. doi: 10.1111/ddg.12294. Review.

20.

WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, 19-20 April 2007.

Joung J, Robertson JS, Griffiths E, Knezevic I; WHO Informal Consultation Group..

Biologicals. 2008 Jul;36(4):269-76. doi: 10.1016/j.biologicals.2007.11.004. Epub 2008 Jan 22.

PMID:
18218324

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