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Reportlinker Adds Biosimilars and Follow-On Biologics: Global Market Outlook 2010-2025 - Opportunities and Challenges in this Emerging Market With High Potential
Date:6/29/2010

lopment of Regulations for the Approval of Biosimilars

4.5.1 Key Issues for Development of Biosimilar Regulations

4.5.2 Requirements for Clinical Trials

4.5.3 Debate over Clinical Trial Requirements in the US

4.5.4 Data Exclusivity Period

4.5.5 Biosimilar Substitution

4.5.6 International Non-Proprietary Names (INNs)

4.6 European Biosimilar Guidelines

4.6.1 EMEA Guidelines for Biosimilar Medicines

4.6.2 Testing Requirements

4.6.3 Clinical Testing For Multiple Indications

4.6.4 Data Exclusivity for Biologic Drugs in the EU

4.6.5 Naming of Biosimilars in the EU

4.6.6 Biosimilar Substitution Not Allowed in the EU

4.6.7 Latest Developments in EMEA Biosimilar Guidelines

4.6.8 Future Development of EMEA Guidelines

4.7 Progress Towards Development of 'Follow-On Protein Products' Regulatory Pathway in the US

4.7.1 Lack of Biosimilar Regulatory Pathway in the US Restricted the Market

4.7.2 Issues Affecting 'Follow-on Protein Products' Legislation in the US

4.7.3 Progress in Development and Implementation of a Biosimilar Regulatory Pathway in the US, 2010

4.8 Biosimilar Regulations in Japan

4.8.1 Japanese Guidelines for Biosimilar Approvals, 2009

4.8.2 Guidelines for the Development of a Biosimilar in Japan


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