pharmabio consulting
  • Orphan Drugs Summit 2016
  • The opportunities and challenges of biosimilar orphans
  • 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-Blasco
  • OPPORTUNITY OF A NEW CLASS OF BIOSIMILAR ORPHAN BIOLOGIC MEDICINES OFFERING ACCESS TO AFFORDABLE MEDICINE
  • Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
  • Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
  • Advancement of Biosimilars Development  by Dr. Hoss A Dowlat
  • Prefilled Syringes and Related Biologic Drug/Devices: Market Trends and Regulatory Acceptability
  • How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006—Part 1
  • How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006—Part 2

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