Affordable Access

deepdyve-link
Publisher Website

Biosimilars and regulatory authorities.

Authors
  • Minghetti, Paola
  • Rocco, Paolo
  • Del Vecchio, Lucia
  • Locatelli, Francesco
Type
Published Article
Journal
Nephron Clinical Practice
Publisher
S. Karger AG
Publication Date
Jan 01, 2011
Volume
117
Issue
1
Identifiers
DOI: 10.1159/000319640
PMID: 20689318
Source
Medline
License
Unknown

Abstract

The patent expirations for many biotechnological medicines have prompted the development of copies of biological medicinal products. Unlike generics, biosimilars are similar but not identical to their reference product, because their chemical characteristics are directly related to the manufacturing process which cannot be precisely duplicated. The regulatory policy for biosimilars is complex and in Europe it is regulated mainly by guidelines issued by the European Medicines Agency (EMEA); additional product-class specific guidelines have been developed as in the case of recombinant human erythropoietin (rHuEPO). In 2008, the experience gained with this drug has prompted the development of a new guideline, currently in draft. In this review we critically discuss aspects related to EMEA guidelines, particularly focusing on rHuEPO.

Report this publication

Statistics

Seen <100 times