The Regulatory Environment for Biopharmaceuticals in the EU

Modern Biopharmaceuticals: Design, Development and Optimization

Volumn 4, Issue , 2008, Pages 1669-1708

  Wenzel, Axel F ^a   Sonnega, Carina E A ^b  

^a Pharma Scientific Services Team   (Germany)

^b NONE

Author keywords

Biogenerics; Carcinogenicity; Pharmacovigilance; Posology; Thalidomide

Indexed keywords

EID: 84889956486     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9783527620982.ch69     Document Type: Chapter

References (16)

1. McGettigan, G. 2002. Performance of regulatory agencies and applicants in the registration of new drugs from January 1995 to June 2001. Northstar Report, Section A, GMG Bio-Business, London.
2. Knäblein, J. 2003. Biotech: a new era in the new millennium? Fermentation and expression of biopharmaceuticals in plants. Screening: Trends Drug Discov 4, 14-16.
3. Knäblein, J. 2004. Biopharmaceuticals expressed in plants - a new era in the new Millennium. In: Müller, R., Kayser, O. (Eds.), Applications in Pharmaceutical Biotechnology. Wiley-VCH, Weinheim, pp. 35-56.
4. Knäblein, J. 2005. Plant-based expression of biopharmaceuticals. In: Meyers, R. A. (Ed.), Encyclopedia of Molecular Cell Biology and Molecular Medicine, 2nd edn. Wiley, New York, vol. 10, pp. 489-510.
5. Knäblein, J., McCaman, M. 2003. Modern biopharmaceuticals - recombinant protein expression in transgenic plants. Screening: Trends Drug Discov 6, 33-35.
6. Oehler-Tomamichel, K. 2005. Comparability of biotechnological/biological products: Comparison between harmonised and regional guidelines on post-approval changes to their manufacturing process and implications for European companies. The Regulatory Rapporteur 2.2.
7. Snodin, D.J. 2005. Biogenerics: nonclinical aspects. The Regulatory Rapporteur 2.2.
8. Taylor, H. 2004. Characterization and specifications for biopharmaceuticals. The Regulatory Rapporteur 1.12.
9. Wenzel, A. 2001. The e future in drug regulatory affairs. The ESRA Rapporteur 8.2.
10. Hennings, G. 2002. Generic medicinal products from biotechnology: do they exist today, will they exist in future? The ESRA Rapporteur 9.6.
11. Zeid, R. L. 2000. Regulatory and development issues in the demonstration of therapeutic equivalence for multisource biotech-derived pharmaceuticals. Drug Inform J 34, 919-959.
12. Chamberlain, P. 2004. Biogenerics: Europe takes another step forward while the FDA dives for cover, Drug Discov Today 9, 817-820.
13. Anon, A. 2004. Biogenerics: EU patent on Amgen's EPO expires but no sign of a generic, SCRIP 3015 (Dec 22), 18-19.
14. Herrera, S. 2004. Biogenerics standoff, Nat Biotechnol 22, 1343-1346.
15. Wenzel, A. 2003. Drug regulatory affairs for biotech drugs. The ESRA Rapporteur 10.3.
16. Wenzel, A. 2004. Drug regulatory aspects of biotechnology derived drugs. Presentation at Farmaci Biotecnologici: Problematiche Formulative e Regolatorie, February 2000.