PharmaBio’s Articles
PharmaBio’s recent and current articles in drug/biologics/biosimilars development in the EU and USA, articles include:
Hoss Dowlat, (Regulatory focus), Fresh insights into the practicalities of developing biosimilar biologics, October 2009.
Hoss Dowlat, N.O.C., (CAPRA), European and canadian experience providing insights into developing biosimilar or subsequent entry biologics, Number 74, Spring 2010.
Hoss Dowlat, Rapporteur (TOPRA), The current status of biosimilar biologics – an international perspective, part 1, p.24-27, 2010. Regulatory Rapporteur – Vol 7, No 9, September 2010, p.24-27.
Hoss Dowlat, Rapporteur (TOPRA), The current status of biosimilar biologics – PART 2: Practical considerations in international development through european lessons learned, 2010. Regulatory Rapporteur – Vol 7, No 10, October 2010.
Hoss Dowlat, Rapporteur (TOPRA), The importance and impact of the eu rmp and us rems to risk–benefit assessments, Regulatory Rapporteur – Vol 8, No 2, February 2011.
Hoss Dowlat & KL Rost, Biosimilars Breaching Borders: How FDA & EMA Find Common Ground, Regulatory Focus (USA), March 2012.
Hoss Dowlat, Perceptions and reality of clinical safety of biosimilars, present and future: EU perspectives and US prospects, 2012 Part 1, Regulatory Rapporteur – Vol 9, No 4, April 2012.
Hoss Dowlat, Perceptions and reality of clinical safety of biosimilars, present and future: EU perspectives and US prospects, 2012 Part 2, Regulatory Rapporteur – Vol 9, No 5, May 2012.
Hoss Dowlat, How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006, Regulatory Focus (USA), Part 1. Regulatory Focus (USA), May 2012.
Hoss Dowlat, How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006, Regulatory Focus (USA), Part 2. July 2012.
RAPS, Fundamentals of International Regulatory Affairs, Second Edition, Advancement of Biosimilars Development in Europe, USA, and Internationally, 2013.
Choosing the optimal prefilled syringes and related biologic drug/devices and their regulatory FDA/EMA acceptability, American Pharmaceutical Review, April 2013.
A. Dowlat*, M. K. Kuhlmann, H. Khatami & F. J. Ampudia-Blasco, 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.
Biosimilar of Orphans, article (p.1 of 10)
Hoss A Dowlat, The opportunities and challenges of biosimilar orphans (editorial), Expert Opinion on Orphan Drugs (Informa publishers), April 2016. http://www.tandfonline.com/eprint/NHakDzmIvANjIj7eNjj9/full.
