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Items: 1 to 20 of 89

1.

The role of the quality assessment in the determination of overall biosimilarity: a simulated case study exercise.

Schiestl M, Li J, Abas A, Vallin A, Millband J, Gao K, Joung J, Pluschkell S, Go T, Kang HN.

Biologicals. 2014 Mar;42(2):128-32. doi: 10.1016/j.biologicals.2013.11.009. Epub 2013 Dec 24.

PMID:
24373974
2.

Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval.

Kudrin A, Knezevic I, Joung J, Kang HN.

Biologicals. 2015 Jan;43(1):1-10. doi: 10.1016/j.biologicals.2014.11.002. Epub 2014 Nov 29. Review.

PMID:
25467836
3.
4.

Establishment of reference standards in biosimilar studies.

Zhang A, Tzeng JY, Chow SC.

GaBI J. 2013 Jul 31;2(4):173-177.

5.

Statistical considerations in biosimilar assessment using biosimilarity index.

Zhang A, Tzeng JY, Chow SC.

J Bioequiv Availab. 2013 Sep 2;5(5):209-214.

6.

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
7.

Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab.

Ebbers HC, van Meer PJ, Moors EH, Mantel-Teeuwisse AK, Leufkens HG, Schellekens H.

Drug Discov Today. 2013 Sep;18(17-18):872-9. doi: 10.1016/j.drudis.2013.05.004. Epub 2013 May 18. Review.

PMID:
23688584
8.

Statistical methods for assessment of biosimilarity using biomarker data.

Chow SC, Lu Q, Tse SK, Chi E.

J Biopharm Stat. 2010 Jan;20(1):90-105. doi: 10.1080/10543400903280373. Review.

PMID:
20077251
9.

A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products.

Schiestl M.

Biologicals. 2011 Sep;39(5):297-9. doi: 10.1016/j.biologicals.2011.06.014. Epub 2011 Jul 23. Review.

10.

Similar biological medicinal products containing recombinant human growth hormone: European regulation.

Pavlovic M, Girardin E, Kapetanovic L, Ho K, Trouvin JH.

Horm Res. 2008;69(1):14-21. Epub 2007 Dec 4. Review.

11.

Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility.

Wadhwa M, Knezevic I, Kang HN, Thorpe R.

Biologicals. 2015 Sep;43(5):298-306. doi: 10.1016/j.biologicals.2015.06.004. Epub 2015 Jul 3. Review.

12.

Regulatory guideline for biosimilar products in Korea.

Suh SK, Park Y.

Biologicals. 2011 Sep;39(5):336-8. doi: 10.1016/j.biologicals.2011.06.008. Epub 2011 Jul 23. Review.

13.

Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010).

Kang HN.

Biologicals. 2011 Sep;39(5):304-7. doi: 10.1016/j.biologicals.2011.08.007.

14.

Immunogenicity assessment of monoclonal antibody products: A simulated case study correlating antibody induction with clinical outcomes.

Knezevic I, Kang HN, Thorpe R.

Biologicals. 2015 Sep;43(5):307-17. doi: 10.1016/j.biologicals.2015.06.009. Epub 2015 Jul 26. Review.

15.

Characterization and comparison of commercially available TNF receptor 2-Fc fusion protein products.

Tan Q, Guo Q, Fang C, Wang C, Li B, Wang H, Li J, Guo Y.

MAbs. 2012 Nov-Dec;4(6):761-74. doi: 10.4161/mabs.22276. Epub 2012 Oct 2.

16.

Scientific factors and current issues in biosimilar studies.

Chow SC, Endrenyi L, Lachenbruch PA, Mentré F.

J Biopharm Stat. 2014;24(6):1138-53. doi: 10.1080/10543406.2014.948961.

PMID:
25098559
17.

Comparability of critical quality attributes for establishing biosimilarity.

Liao JJ, Darken PF.

Stat Med. 2013 Feb 10;32(3):462-9. doi: 10.1002/sim.5564. Epub 2012 Aug 17.

PMID:
22903263
18.

[The Polish Task Force position statement on safety of biologic treatment with monoclonal antibodies and soluble receptors].

Jahnz-Rozyk K, Wiesik-Szewczyk E; Grupa Ekspertów.

Pol Merkur Lekarski. 2014 Jul;37(217):5-9. Polish.

PMID:
25154192
19.

Biosimilar structural comparability assessment by NMR: from small proteins to monoclonal antibodies.

Japelj B, Ilc G, Marušič J, Senčar J, Kuzman D, Plavec J.

Sci Rep. 2016 Aug 31;6:32201. doi: 10.1038/srep32201.

20.

Quality, safety and efficacy of follow-on biologics in Japan.

Yamaguchi T, Arato T.

Biologicals. 2011 Sep;39(5):328-32. doi: 10.1016/j.biologicals.2011.06.015. Epub 2011 Sep 3. Review.

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