After consultation with industry, the FDA published draft biosimilars
guidelines in February 2012. Although details are lacking in a number of areas
such as interchangeability, the guidance sets out the agency's broad views and
gives developers greater certainty for the initiation of development programs.
Features and benefits
Insight into the key biosimilar regulatory developments globally
Assessment of the key strategies incorporated by players as a response to
these changes in biosimilar regulation
Highlights
The FDA published draft biosimilars guidelines in February 2012.
In the EU, the EMA has published guidance for the development of interferon
beta biosimilars.
In order to meet physician and patient demands for more complex drugs and
reduce the financial burden on payers, the Iranian government is keen to
promote the Iranian biosimilars industry.
Your key questions answered
Evaluate the evolving regulatory environment around the world and how this
impacts biosimilar market access and uptake.
Gain insight into the strategies employed by payers and pharmaceutical
companies as a response to these changes in the regulatory environment.
Table of Contents
Table of Contents
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
Biosimilars: Global Regulatory Update published by Datamonitor in May 2, 2012. This report consists of Pages: 31 and the price starts from US $ 3800.
