Switching Between Epoetins: A Practice in Support of Biosimilar Use

Author:

D’Amore Carmen,Da Cas Roberto,Rossi Mariangela,Traversa Giuseppe

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Reference11 articles.

1. European Medicines Agency. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins. (EMEA/CHMP/BMWP/301636/2008). 2010. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/04/WC500089474.pdf . Accessed 5 Aug 2015.

2. Ebbers HC, Muenzberg M, Schellekens H. The safety of switching between therapeutic proteins. Expert Opin Biol Ther. 2012;12:1473–85.

3. Więcek A, Ahmed I, Scigalla P, Koytchev R. Switching epoetin alfa and epoetin zeta in patients with renal anemia on dialysis: posthoc analysis. Adv Ther. 2010;27:941–52.

4. AIFA position paper. I farmaci biosmilari. 2013. http://www.agenziafarmaco.gov.it/sites/default/files/AIFA_POSITION_PAPER_FARMACI_BIOSIMILARI.pdf . Accessed 5 Aug 2015.

5. Farmaci biosimilari: sicurezza, efficacia, omogeneità di trattamento e corretta informazione. Un Manifesto dei diritti dei pazienti. 2014. http://www.amrer.it/download_documenti/manifesto-farmaci-biosimilari.pdf . Accessed 17 Dec 2015.

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