pharmabio consulting

Dr. Hoss A Dowlat

Dr. Hoss A Dowlat
Vice President, Regulatory Affairs


Hoss leads an international team of drug development Principal Consultants at his self-owned PHARMABIO CONSULTING. His experience encompasses strategic regulatory support and Due Diligence to circa. 90 client companies from across Europe, America, Canada, China, Korea, Taiwan, Japan, and India and the financial sector New York US and London UK.

Hoss was until 2010 Vice-President, Technical, Drug Development and Regulatory Global Strategy Services, at the leading CRO PAREXEL International. In PAREXEL CONSULTING 2000-2010 he provided a direct consulting service to more than 50 Pharma client companies. Prior to this he was leading drug development programs and registrations in several international Pharma companies.

Hoss is British-Canadian educated in England to B.Sc. and PhD level, and was also a recipient of a Post-doctoral European Royal Society Fellowship award in organic chemistry. He has more than 31 years of drug development experience in over 15 therapeutic areas in the EU and North American pharmaceutical industry, 21 years of which have been in regulatory affairs.

His strength is in therapeutic proteins such as novel and biosimilar monoclonal antibodies. He has substantial Orphan Drugs development experience additionally, and is applying it to niche area of orphan biosimilars. Has unique insights into the FDA-EMA requirements.

Extensive experience preparing clients for FDA meetings and has led, managed and attended FDA meetings across Divisions/Offices, in particular, formal Type B, NDA/BLA and BsUFA ABLA Advice (5 types) and presubmission meetings. Highly experienced with EU: MAA presubmission EMA meetings, MAA presubmission Rapporteur/Co-rapporteur, D120 and D180 Clarification meetings, Oral Explanations, and SAWP/CHMP/EMA Scientific Advice.

Pioneer in European biosimilar approvals as regulatory lead to one of 2 EU Biosimilar MA hGH approvals in April 2006.

Hoss has published 5 milestone articles on biosimilars in 2012; March (US), April (EU), May (EU), May (US) and July (US), and a RAPS book biosimilars chapter in 2013, and broadcasts to US and EU monthly thought leadership professional webinars 2011-present. The latest international article in progress 2015 is on “Interchangeability among reference insulins and their biosimilars: regulatory framework, study design, and clinical implications”.

He is also a well-established international trainer (to Pharma and Agencies) and conference and webinar presenter in EU/US regulatory affairs, biologics/biosimilars, scientific advice, the Common Technical Dossier (MAA/NDA/BLA), labeling (prescriber and patient), clinical safety, pharmaceutical development, and combination drugs.
Some published biosimilars articles by Hoss:
Regulatory Focus, Journal of the Regulatory Affairs Professional Society (international) (RAPS):

  • Biosimilars Breaching Borders: How FDA and EMA Find Common Ground, March, 2012.
  • How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006, Pt 1, May; Pt 2, July 2012.

Regulatory Rapporteur, The International Journal for Professionals in Regulatory Affairs (TOPRA):

  • Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Pt 1, April; Pt 2, May 2012.
  • RAPS, Fundamentals of International Regulatory Affairs, Second Edition, Advancement of Biosimilars Development in Europe, USA, and Internationally, 2013.
  • Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications, Diabetes, Obesity and Metabolism 2016 (John Wiley & Sons Ltd). doi:10.1111/dom.12676 3.
  • The opportunities and challenges of biosimilar orphans (editorial), Expert Opinion on Orphan Drugs (Informa publishers), April 2016.



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