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Results: 1 to 20 of 106

1.

Similar biotherapeutic products: overview and reflections.

Desanvicente-Celis Z, Gomez-Lopez A, Anaya JM.

Immunotherapy. 2012 Dec;4(12):1841-57. doi: 10.2217/imt.12.128. Review.

PMID:
23240752
[PubMed - indexed for MEDLINE]
2.

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
[PubMed - indexed for MEDLINE]
3.

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
[PubMed - indexed for MEDLINE]
4.

Therapeutic monoclonal antibodies: strategies and challenges for biosimilars development.

Calvo B, Zuñiga L.

Curr Med Chem. 2012;19(26):4445-50. Review.

PMID:
22978327
[PubMed - indexed for MEDLINE]
5.

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]
6.

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
[PubMed - indexed for MEDLINE]
7.

Rituximab biosimilars.

Vital EM, Kay J, Emery P.

Expert Opin Biol Ther. 2013 Jul;13(7):1049-62. doi: 10.1517/14712598.2013.787064. Epub 2013 Apr 22. Review.

PMID:
23600760
[PubMed - indexed for MEDLINE]
8.

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
[PubMed - indexed for MEDLINE]
9.

Biosimilars clinical development program: confirmatory clinical trials: a virtual/simulated case study comparing equivalence and non-inferiority approaches.

Fletcher MP.

Biologicals. 2011 Sep;39(5):270-7. doi: 10.1016/j.biologicals.2011.06.004. Epub 2011 Aug 27.

PMID:
21875812
[PubMed - indexed for MEDLINE]
Free Article
10.

Is it time for biosimilars in autoimmune diseases?

Cuadrado MJ, Sciascia S, Bosch X, Khamashta MA, Ramos-Casals M.

Autoimmun Rev. 2013 Aug;12(10):954-7. doi: 10.1016/j.autrev.2013.02.005. Epub 2013 Mar 28. Review.

PMID:
23542505
[PubMed - indexed for MEDLINE]
11.

Biosimilars in oncology: from development to clinical practice.

Rak Tkaczuk KH, Jacobs IA.

Semin Oncol. 2014 Apr;41 Suppl 3:S3-S12. doi: 10.1053/j.seminoncol.2014.03.008. Epub 2014 Mar 13. Review.

PMID:
24767633
[PubMed - indexed for MEDLINE]
Free Article
12.

[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]
13.

Biosimilar insulins.

Heinemann L.

Expert Opin Biol Ther. 2012 Aug;12(8):1009-16. doi: 10.1517/14712598.2012.688024. Epub 2012 May 15. Review.

PMID:
22583127
[PubMed - indexed for MEDLINE]
14.

Anti-neoplastic biosimilars--the same rules as for cytotoxic generics cannot be applied.

Mellstedt H.

Ann Oncol. 2013 Sep;24 Suppl 5:v23-8. doi: 10.1093/annonc/mdt325.

PMID:
23975701
[PubMed - indexed for MEDLINE]
15.

Biosimilars: the 'future' of biologic therapy?

Ranjan N, Mahajan VK, Misra M.

J Dermatolog Treat. 2011 Dec;22(6):319-22. doi: 10.3109/09546631003763942. Epub 2010 Jul 28. Review.

PMID:
20666673
[PubMed - indexed for MEDLINE]
16.

Developing oncology biosimilars: an essential approach for the future.

Abraham J.

Semin Oncol. 2013 Dec;40 Suppl 1:S5-24. doi: 10.1053/j.seminoncol.2013.09.015. Review.

PMID:
24267944
[PubMed - indexed for MEDLINE]
17.

A consistency approach for evaluation of biosimilar products.

Tsou HH, Chang WJ, Hwang WS, Lai YH.

J Biopharm Stat. 2013;23(5):1054-66. doi: 10.1080/10543406.2013.813518.

PMID:
23957515
[PubMed - indexed for MEDLINE]
18.

From "blockbusters" to "biosimilars": an opportunity for patients, medical specialists and health care providers.

Braido F, Holgate S, Canonica GW.

Pulm Pharmacol Ther. 2012 Dec;25(6):483-6. doi: 10.1016/j.pupt.2012.09.005. Epub 2012 Sep 23.

PMID:
23010202
[PubMed - indexed for MEDLINE]
19.

Biosimilars: the paradox of sharing the same pharmacological action without full chemical identity.

Pani L, Montilla S, Pimpinella G, Bertini Malgarini R.

Expert Opin Biol Ther. 2013 Oct;13(10):1343-6. doi: 10.1517/14712598.2013.815722. Epub 2013 Jun 28.

PMID:
23805906
[PubMed - indexed for MEDLINE]
20.

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
[PubMed - indexed for MEDLINE]

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