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Items: 1 to 20 of 688

1.

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
2.

Biosimilars: A consideration of the regulations in the United States and European union.

Daller J.

Regul Toxicol Pharmacol. 2016 Apr;76:199-208. doi: 10.1016/j.yrtph.2015.12.013. Epub 2015 Dec 28.

PMID:
26732800
3.

Worldwide experience with biosimilar development.

McCamish M, Woollett G.

MAbs. 2011 Mar-Apr;3(2):209-17. Epub 2011 Mar 1.

4.

Pharmacovigilance and biosimilars: considerations, needs and challenges.

Casadevall N, Edwards IR, Felix T, Graze PR, Litten JB, Strober BE, Warnock DG.

Expert Opin Biol Ther. 2013 Jul;13(7):1039-47. doi: 10.1517/14712598.2013.783560. Epub 2013 Mar 26. Review.

PMID:
23527621
5.

[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
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
7.

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
8.

Development and regulation of biosimilars: current status and future challenges.

Tsiftsoglou AS, Ruiz S, Schneider CK.

BioDrugs. 2013 Jun;27(3):203-11. doi: 10.1007/s40259-013-0020-y. Review.

PMID:
23553340
9.

Biosimilars: opinion of an expert panel in the Middle East.

Bohlega S, Al-Shammri S, Al Sharoqi I, Dahdaleh M, Gebeily S, Inshasi J, Khalifa A, Pakdaman H, Szólics M, Yamout B.

Curr Med Res Opin. 2008 Oct;24(10):2897-903. doi: 10.1185/03007990802381554 . Epub 2008 Sep 2. Review.

PMID:
18768104
10.

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
11.

Development of biosimilars.

Al-Sabbagh A, Olech E, McClellan JE, Kirchhoff CF.

Semin Arthritis Rheum. 2016 Apr;45(5 Suppl):S11-8. doi: 10.1016/j.semarthrit.2016.01.002. Epub 2016 Jan 21. Review.

PMID:
26947440
12.
13.

Biosimilar drugs: Current status.

Kumar R, Singh J.

Int J Appl Basic Med Res. 2014 Jul;4(2):63-6. doi: 10.4103/2229-516X.136774. Review.

14.

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
15.

[Biosimilars].

Krämer I.

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

PMID:
22045529
16.

Biosimilars: Practical Considerations for Pharmacists.

Stevenson JG, Popovian R, Jacobs I, Hurst S, Shane LG.

Ann Pharmacother. 2017 Jul;51(7):590-602. doi: 10.1177/1060028017690743. Epub 2017 Feb 8.

PMID:
28176529
17.

A practical guide about biosimilar data for health care providers treating inflammatory diseases.

Markenson J, Alvarez DF, Jacobs I, Kirchhoff C.

Biologics. 2017 Feb 24;11:13-21. doi: 10.2147/BTT.S122335. eCollection 2017. Review.

18.

Biosimilars: current scientific and regulatory considerations.

Chugh PK, Roy V.

Curr Clin Pharmacol. 2014 Feb;9(1):53-63.

PMID:
23952143
19.

Biosimilars 101: considerations for U.S. oncologists in clinical practice.

Camacho LH, Frost CP, Abella E, Morrow PK, Whittaker S.

Cancer Med. 2014 Aug;3(4):889-99. doi: 10.1002/cam4.258. Epub 2014 May 9. Review.

20.

Biosimilars: Rationale and current regulatory landscape.

Olech E.

Semin Arthritis Rheum. 2016 Apr;45(5 Suppl):S1-10. doi: 10.1016/j.semarthrit.2016.01.001. Epub 2016 Jan 21. Review.

PMID:
26947438

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