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- Title
EMEA Tackles ‘Generic’ Biologic Drug Issues.
- Authors
Rice, Mary
- Abstract
The article reports on the issues pertaining to biosimilar drug regulations that the European Medicines Evaluation Agency have to deal. There is an increasing pressure on finding ways to secure license regarding the patents on biotechnological drugs expiration. The agency has adopted the first guidelines on quality and non-clinical issues relating to these products.
- Subjects
BIOLOGICAL products; PHARMACEUTICAL policy; DRUG approval; BIOTECHNOLOGY industries; PATENTS; EUROPEAN Union. European Medicines Evaluation Agency; EUROPEAN Union
- Publication
JNCI: Journal of the National Cancer Institute, 2006, Vol 98, Issue 7, p435
- ISSN
0027-8874
- Publication type
Article
- DOI
10.1093/jnci/djj145