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History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology.

Kalantar-Zadeh K.

Am J Nephrol. 2017;45(3):235-247. doi: 10.1159/000455387. Epub 2017 Feb 1.


What do oncologists need to know about biosimilar products?

Leung LK, Mok K, Liu C, Chan SL.

Chin J Cancer. 2016 Oct 13;35(1):91. Review.


Peginesatide for the treatment of anemia due to chronic kidney disease - an unfulfilled promise.

Hermanson T, Bennett CL, Macdougall IC.

Expert Opin Drug Saf. 2016 Oct;15(10):1421-6. doi: 10.1080/14740338.2016.1218467. Epub 2016 Aug 23. Review.


Association of Erythropoietin Dose and Route of Administration with Clinical Outcomes for Patients on Hemodialysis in the United States.

Wright DG, Wright EC, Narva AS, Noguchi CT, Eggers PW.

Clin J Am Soc Nephrol. 2015 Oct 7;10(10):1822-30. doi: 10.2215/CJN.01590215. Epub 2015 Sep 10.


Clinical Immunogenicity of rHuPH20, a Hyaluronidase Enabling Subcutaneous Drug Administration.

Rosengren S, Dychter SS, Printz MA, Huang L, Schiff RI, Schwarz HP, McVey JK, Drake FH, Maneval DC, Kennard DA, Frost GI, Sugarman BJ, Muchmore DB.

AAPS J. 2015 Sep;17(5):1144-56. doi: 10.1208/s12248-015-9782-0. Epub 2015 May 13. Erratum in: AAPS J. 2015 Nov;17(6):1523-4.


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.


Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS).

Macdougall IC, Casadevall N, Locatelli F, Combe C, London GM, Di Paolo S, Kribben A, Fliser D, Messner H, McNeil J, Stevens P, Santoro A, De Francisco AL, Percheson P, Potamianou A, Foucher A, Fife D, Mérit V, Vercammen E; PRIMS study group..

Nephrol Dial Transplant. 2015 Mar;30(3):451-60. doi: 10.1093/ndt/gfu297. Epub 2014 Sep 19.


Pharmacovigilance in practice: erythropoiesis-stimulating agents.

Hedenus M, Ludwig H, Henry DH, Gasal E.

Cancer Med. 2014 Oct;3(5):1416-29. doi: 10.1002/cam4.275. Epub 2014 Jun 3. Review.


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.


Biosimilars: Implications for health-system pharmacists.

Lucio SD, Stevenson JG, Hoffman JM.

Am J Health Syst Pharm. 2013 Nov 15;70(22):2004-17. doi: 10.2146/ajhp130119.


Immunogenicity of therapeutic proteins: influence of aggregation.

Ratanji KD, Derrick JP, Dearman RJ, Kimber I.

J Immunotoxicol. 2014 Apr-Jun;11(2):99-109. doi: 10.3109/1547691X.2013.821564. Epub 2013 Aug 6. Review.


Erythropoiesis stimulating agents: approaches to modulate activity.

Sinclair AM.

Biologics. 2013;7:161-74. doi: 10.2147/BTT.S45971. Epub 2013 Jul 3.


Follow-on biologics in oncology - the need for global and local regulations.

Hus I.

Contemp Oncol (Pozn). 2012;16(6):461-6. doi: 10.5114/wo.2012.32475. Epub 2013 Jan 4.


Immunoglobulin G1 and immunoglobulin G4 antibodies in multiple sclerosis patients treated with IFNβ interact with the endogenous cytokine and activate complement.

Sethu S, Govindappa K, Quinn P, Wadhwa M, Stebbings R, Boggild M, Naisbitt D, Kimber I, Pirmohamed M, Park K, Sathish J.

Clin Immunol. 2013 Aug;148(2):177-85. doi: 10.1016/j.clim.2013.05.008. Epub 2013 May 22.


Results from the first decade of research conducted by the Research on Adverse Drug Events and Reports (RADAR) project.

McKoy JM, Fisher MJ, Courtney DM, Raisch DW, Edwards BJ, Scheetz MH, Belknap SM, Trifilio SM, Samaras AT, Liebling DB, Nardone B, Tulas KM, West DP.

Drug Saf. 2013 May;36(5):335-47. doi: 10.1007/s40264-013-0042-x. Review.


Bisphosphonates and nonhealing femoral fractures: analysis of the FDA Adverse Event Reporting System (FAERS) and international safety efforts: a systematic review from the Research on Adverse Drug Events And Reports (RADAR) project.

Edwards BJ, Bunta AD, Lane J, Odvina C, Rao DS, Raisch DW, McKoy JM, Omar I, Belknap SM, Garg V, Hahr AJ, Samaras AT, Fisher MJ, West DP, Langman CB, Stern PH.

J Bone Joint Surg Am. 2013 Feb 20;95(4):297-307. doi: 10.2106/JBJS.K.01181. Review.


Long-term and stable correction of uremic anemia by intramuscular injection of plasmids containing hypoxia-regulated system of erythropoietin expression.

Sun J, Wang Y, Yang J, Du D, Li Z, Wei J, Yang A.

Exp Mol Med. 2012 Nov 30;44(11):674-83. doi: 10.3858/emm.2012.44.11.076.


Improved drug-like properties of therapeutic proteins by directed evolution.

Buchanan A, Ferraro F, Rust S, Sridharan S, Franks R, Dean G, McCourt M, Jermutus L, Minter R.

Protein Eng Des Sel. 2012 Oct;25(10):631-8. Epub 2012 Aug 31.


Linking drugs to obscure illnesses: lessons from pure red cell aplasia, nephrogenic systemic fibrosis, and Reye's syndrome. a report from the Southern Network on Adverse Reactions (SONAR).

Bennett CL, Starko KM, Thomsen HS, Cowper S, Sartor O, Macdougall IC, Qureshi ZP, Bookstaver PB, Miller AD, Norris LB, Xirasagar S, Trenery A, Lopez I, Kahn A, Murday A, Luminari S, Cournoyer D, Locatelli F, Ray P, Mattison DR.

J Gen Intern Med. 2012 Dec;27(12):1697-703. doi: 10.1007/s11606-012-2098-1. Epub 2012 Jun 13. Review.

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