PHARMABIO Consulting

Publications

Selected articles and papers

• Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications H. A. Dowlat*, M. K. Kuhlmann, H. Khatami & F. J. Ampudia-BlascoPublished June 15, 2016 at 4:30 am
• How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006—Part 1Published July 26, 2012 at 7:33 pm
• How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006—Part 2Published July 26, 2012 at 7:27 pm
• Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Part 2Published April 17, 2012 at 9:06 am
• Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Part 1Published March 21, 2012 at 12:45 am
• Biosimilars Breaching Borders: How FDA and EMA Find Common GroundPublished March 8, 2012 at 11:48 am
• The importance and impact of the EU RMP and US REMS to risk-benefit assessmentsPublished January 28, 2011 at 10:32 pm
• The current status of biosimilar biologics – Part 1: An international perspective.Published January 4, 2011 at 1:21 pm