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Results: 1 to 20 of 137

1.

Clinical development of biosimilars: an evolving landscape.

Subramanyam M.

Bioanalysis. 2013 Mar;5(5):575-86. doi: 10.4155/bio.13.5. Review.

PMID:
23425273
[PubMed - indexed for MEDLINE]
2.

European perspective on biosimilars.

Wadhwa M, Thorpe R.

Bioanalysis. 2013 Mar;5(5):521-4. doi: 10.4155/bio.13.2. No abstract available.

PMID:
23425266
[PubMed - indexed for MEDLINE]
3.

Nonclinical development of a biosimilar: the current landscape.

O'Connor A, Rogge M.

Bioanalysis. 2013 Mar;5(5):537-44. doi: 10.4155/bio.13.7.

PMID:
23425270
[PubMed - indexed for MEDLINE]
4.

A wide angle view of biosimilars from a bioanalytical perspective.

Oldfield P.

Bioanalysis. 2013 Mar;5(5):533-5. doi: 10.4155/bio.12.316. No abstract available.

PMID:
23425269
[PubMed - indexed for MEDLINE]
5.

Biosimilar rhG-CSFs: how similar are they?

Gravel P, Naik A, Le Cotonnec JY.

Target Oncol. 2012 Mar;7 Suppl 1:S3-16. doi: 10.1007/s11523-011-0187-4. Epub 2012 Feb 9.

PMID:
22318351
[PubMed - indexed for MEDLINE]
6.

Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development.

Cai XY, Wake A, Gouty D.

Bioanalysis. 2013 Mar;5(5):517-20. doi: 10.4155/bio.13.1. No abstract available.

PMID:
23425265
[PubMed - indexed for MEDLINE]
Free Article
7.

Epoetin biosimilars in Europe: five years on.

Mikhail A, Farouk M.

Adv Ther. 2013 Jan;30(1):28-40. doi: 10.1007/s12325-012-0072-2. Epub 2012 Dec 12. Review.

PMID:
23242745
[PubMed - indexed for MEDLINE]
8.

Mini Focus: bioanalysis of biosimilars.

Amaravadi L, Marini J.

Bioanalysis. 2013 Mar;5(5):515-6. doi: 10.4155/bio.13.26. No abstract available.

PMID:
23425264
[PubMed - indexed for MEDLINE]
Free Article
9.

Gel electrophoretic methods for the analysis of biosimilar pharmaceuticals using the example of recombinant erythropoietin.

Reichel C, Thevis M.

Bioanalysis. 2013 Mar;5(5):587-602. doi: 10.4155/bio.13.9. Review.

PMID:
23425274
[PubMed - indexed for MEDLINE]
10.

Conference Report: Bioanalysis-related topics presented at the International Conference and Exhibition on Biowaivers and Biosimilars.

Colletti KS.

Bioanalysis. 2013 Mar;5(5):529-31. doi: 10.4155/bio.12.330.

PMID:
23425268
[PubMed - indexed for MEDLINE]
Free Article
11.

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
[PubMed - indexed for MEDLINE]
12.

Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States.

Ahmed I, Kaspar B, Sharma U.

Clin Ther. 2012 Feb;34(2):400-19. doi: 10.1016/j.clinthera.2011.12.005. Epub 2012 Jan 13. Review.

PMID:
22244050
[PubMed - indexed for MEDLINE]
13.

Biosimilar growth hormone.

Saenger P.

Indian J Pediatr. 2012 Jan;79(1):92-8. doi: 10.1007/s12098-011-0610-y. Epub 2011 Nov 23.

PMID:
22108957
[PubMed - indexed for MEDLINE]
14.

The comparability conundrum: biosimilars in the United States, Europe and Canada.

Courage N, Parsons A.

Food Drug Law J. 2011;66(2):203-24, i-ii.

PMID:
24505840
[PubMed - indexed for MEDLINE]
15.

[Biosimilars].

Krämer I.

Ther Umsch. 2011 Nov;68(11):659-66. doi: 10.1024/0040-5930/a000227. Review. German.

PMID:
22045529
[PubMed - indexed for MEDLINE]
16.

The challenge of biosimilars.

Mellstedt H, Niederwieser D, Ludwig H.

Ann Oncol. 2008 Mar;19(3):411-9. Epub 2007 Sep 14. Review.

PMID:
17872902
[PubMed - indexed for MEDLINE]
Free Article
17.

Biosimilars: controversies as illustrated by rhGH.

Declerck PJ, Darendeliler F, Góth M, Kolouskova S, Micle I, Noordam C, Peterkova V, Volevodz NN, Zapletalová J, Ranke MB.

Curr Med Res Opin. 2010 May;26(5):1219-29. doi: 10.1185/03007991003719642. Review.

PMID:
20302553
[PubMed - indexed for MEDLINE]
18.

Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations.

Dranitsaris G, Amir E, Dorward K.

Drugs. 2011 Aug 20;71(12):1527-36. doi: 10.2165/11593730-000000000-00000. Review.

PMID:
21861538
[PubMed - indexed for MEDLINE]
19.

Biosimilar agents in oncology/haematology: from approval to practice.

Niederwieser D, Schmitz S.

Eur J Haematol. 2011 Apr;86(4):277-88. doi: 10.1111/j.1600-0609.2010.01566.x. Epub 2011 Jan 25. Review.

PMID:
21175852
[PubMed - indexed for MEDLINE]
Free PMC Article
20.

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
[PubMed - indexed for MEDLINE]

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