How Safe Are Biosimilars? - Implications of FDA and EMA Guidances and European Experience since 2006 - Part 2

Written By : Dr. Hoss A Dowlat

VP, Global Strategy, Regulatory Affairs

PharmaBio Consulting, Freiburg, Germany

Published on July 2012
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How Safe Are Biosimilars? - Implications of FDA and EMA Guidances and European Experience since 2006 - Part 1

Written By : Dr. Hoss A Dowlat

VP, Global Strategy, Regulatory Affairs

PharmaBio Consulting, Freiburg, Germany

Published on May 2012
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Biosimilars Breaching Borders: How FDA and EMA Find Common Ground

Written By : Dr. Hoss A Dowlat

VP, Global Strategy, Regulatory Affairs

PharmaBio Consulting, Freiburg, Germany

Published on May 2012
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European and Canadian Experience Providing Insights into DEVELOPING BIOSIMILAR OR SUBSEQUENT ENTRY BIOLOGICS

Written By : Dr. Hoss A Dowlat

VP, Global Strategy, Regulatory Affairs

PharmaBio Consulting, Freiburg, Germany

Published on April 2012
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The importance & impact of the EU RMP& US REMS to risk-benefit assessments

Written By : Dr. Hoss A Dowlat

VP, Global Strategy, Regulatory Affairs

PharmaBio Consulting, Freiburg, Germany

Published on April 2012
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The current status of biosimilar biologics : Part 1: An international perspective

Written By : Dr. Hoss A Dowlat

VP, Global Strategy, Regulatory Affairs

PharmaBio Consulting, Freiburg, Germany

Published on April 2012
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The current status of biosimilar biologics Part 2 : Practical considerations in international development through European lessons learned

Written By : Dr. Hoss A Dowlat

VP, Global Strategy, Regulatory Affairs

PharmaBio Consulting, Freiburg, Germany

Published on April 2012
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Perception And Realities of Clinical Safety of BioSimilars : EU & US Perspectives: Part 1

Written By : Dr. Hoss A Dowlat

VP, Global Strategy, Regulatory Affairs

PharmaBio Consulting, Freiburg, Germany

Published on April 2012
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Perception And Realities of Clinical Safety of BioSimilars : EU & US Perspectives: Part 2

Written By : Dr. Hoss A Dowlat

VP, Global Strategy, Regulatory Affairs

PharmaBio Consulting, Freiburg, Germany

Published on April 2012
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