Biosimilar Oncology Drugs in Europe: Regulatory and Pharmacovigilance Considerations

Author:

Francescon SaraORCID,Fornasier Giulia,Baldo Paolo

Publisher

Springer Science and Business Media LLC

Subject

Oncology

Reference25 articles.

1. European Medicines Agency. Guideline on similar biological medicinal products. London. 2005. http://emea.europa.eu/pdfs/human/biosimilar/043704en.pdf . Accessed 13 July 2016.

2. Decreto Legislativo 10 febbraio 2005, n. 30. Codice della proprietà industriale, a norma dell’articolo 15 della legge 12 dicembre 2002, n. 273.Camera dei Deputati. 2005. http://www.camera.it/parlam/leggi/deleghe/05030dl.htm . Accessed 16 Apr 2016.

3. European Commission. Regolamento (CEE) n. 1768/92 del Consiglio, del 18 giugno 1992, sull’istituzione di un certificato protettivo complementare per i medicinali. 1992. http://eur-lex.europa.eu/eli/reg/1992/1768/oj . Accessed 14 Apr 2016.

4. Baldo P, De Paoli P. Pharmacovigilance in oncology: evaluation of current practice and future perspectives: pharmacovigilance in oncology and current practice. J Eval Clin Pract. 2014;20(5):559–69.

5. European Generic Medicines Association. Factors supporting a sustainable european biosimilar medicines market. Medicines for Europe. 2014. http://www.medicinesforeurope.com/?s=Factors+supporting+a+sustainable+european+biosimilar+medicines+market . Accessed 26 Apr 2016.

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