Comparative testing and pharmacovigilance of biosimilars

Author:

Locatelli Francesco,Roger Simon

Publisher

Oxford University Press (OUP)

Subject

Transplantation,Nephrology

Reference20 articles.

1. Chen ML, Shah V, Patnaik R, et al. (2001) Bioavailability and bioequivalence: an FDA regulatory overview. Pharm Res18:1645–1650.

2. Crommelin D, Bermejo T, Bissig M, et al. (2005) Pharmaceutical evaluation of biosimilars: important differences from generic low-molecular-weight pharmaceuticals. EJHP-S11:11–17.

3. Schellekens H. (2005) Follow-on biologics: challenges of the “next generation”. Nephrol Dial Transplant20:[Suppl 4], iv31–iv36.

4. Casadevall N, Nataf J, Viron B, et al. (2002) Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med346:469–475.

5. Committee for medicinal products for human use (CHMP). Guidelines on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. European Medicines Agency (EMEA) www.emea.eu.int, last accessed 23.11.2005.

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