NEW YORK, June 13, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Biosimilars: Global Regulatory Update
http://www.reportlinker.com/p0885034/Biosimilars-Global-Regulatory-Update.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biopharmaceutical
ABOUT THIS REPORT•PharmaVitae Explorer database
EXECUTIVE SUMMARY•Introduction
•Key findings - Other US biosimilars regulatory issues
- EU biosimilar regulatory developments
- Rest of world biosimilar regulatory developments
- Country-specific biosimilar definitions
•Biosimilars approval pathways
BIOSIMILAR REGULATORY UPDATES•FDA biosimilar development guidelines outline the agency's current thinking - (Untitled sub-section)
- Reference product considerations
- Biosimilar design and manufacturing
- Preclinical studies
- Clinical studies
- Indication extrapolation
- Interchangeability requirements
- Post-marketing requirements
•PDUFA V to be approved by September 2012 - The FDA aims to review biosimilar applications within 10 months
•EU issues new guidelines - EU issues draft interferon beta guidelines
- German reference price cuts to affect biosimilar epoetins
- Belgium to set biosimilar target
•Emerging markets
APPENDIX•References - Datamonitor reports
•Exchange rates
TABLES•Table: Biosimilars approval pathways
•Table: Comparison of biosimilar guidelines across major markets, 2012
•Table: Comparison of biosimilar guidelines across major markets, 2012
•Table: EMA H1 2012 biosimilars guidance timetable
•Table: Pipeline and marketed biosimilar/copy-biologic interferon beta drugs
•Table: Germany – biosimilar epoetin products marketed in Germany, 2012
•Table: Exchange rates, 2011
FIGURES•Figure: The PharmaVitae Explorer
Companies mentioned
Devoteam SA, Hutchison 3G UK Limited, Janssen Pharmaceuticals, Inc., Merck KGaA
To order this report:
: Biosimilars: Global Regulatory Update
Nicolas Bombourg
Reportlinker
Email: [email protected]
US: (805)652-2626
Intl: +1 805-652-2626
SOURCE Reportlinker
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