Boston, MA -- (SBWIRE) -- 07/02/2012 -- 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.

Report Scope

- 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

Report Highlights

The FDA published draft biosimilars guidelines in February 2012.

View Full Report Details and Table of Contents

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

Reasons to Get this Report

- 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.

About Fast Market Research
Fast Market Research is an online aggregator and distributor of market research and business information. Representing the world's top research publishers and analysts, we provide quick and easy access to the best competitive intelligence available. Our unbiased, expert staff will help you find the right research to fit your requirements and your budget. For more information about these or related research reports, please visit our website at http://www.fastmr.com or call us at 1.800.844.8156.

Browse all Pharmaceuticals research reports at Fast Market Research

You may also be interested in these related reports:

- Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment
- Global Biosimilars: A return to optimism?
- Global Biosimilars: Identifying 2nd Generation Opportunities
- The World Generic Market Report 2012
- Global LTE Industry Landscape: Adoption, Applications, Deployments and Subscriptions by Region, Country, Spectrum and Operator 2011 - 2015
- Biologics Price Competition and Innovation (BPCI) Act - Industry Trends Creating Demand for Biosimilars
- Cancer Supportive Care Products Market to 2016 - Market is Expected to Decline after 2014 Due to Generic Erosion and Entry of Biosimilars
- Solar Photovoltaic (PV) Power in Canada, Market Outlook to 2020, 2011 Update - Capacity, Generation, Power Plants, Key Regulations and Company Profiles
- Hydropower (Large and Small Hydro, and Pumped Storage) in Canada, Market Outlook to 2020, 2011 Update - Capacity, Generation, Power Plants, Regulations and Company Profiles
- Biomass Power in Canada, Market Outlook to 2020, 2011 Update - Capacity, Generation, Power Plants, Key Regulations and Company Profiles