Reading the Regulatory Tea Leaves with Peter Pitts and Yin Ho



Similarity is Difficult. Safety is Primary.

Join Peter Pitts and Yin Ho for a presentation about the appropriate pathway for biosimilars.


Welcome Zarxio, the Sandoz version of filgrastim. While nothing is “easy” when it comes to drug development, many view this initial Sandoz experience as forecasting clear skies and fair winds for every biosimilar put in front of the agency for consideration. If you believe that, there’s a bridge in Brooklyn you might find of interest.


Peter Pitts is the president and co-founder of the Center for Medicine in the Public Interest and a member of the Context Matters Advisory Board. He is also a former FDA associate commissioner, advisor to the Obama administration and currently serves as an associate editor of the DIA scientific journal, Therapeutic Innovation & Regulatory Science. His work has been published in New York Times, The Washington Post, Wall Street Journal, and The Economist. Peter also has an informative blog where he debates today’s drug policies. If you’re not already a reader, you should definitely check it out.


Yin Ho is the founder and CEO of Context Matters. A licensed physician, Yin left the practice of medicine in 1998 to focus on the convergence of healthcare and information technology. Prior to founding Context Matters in 2010, Yin was vice president of corporate strategy at Medidata Solutions. She held senior positions at Pfizer, leading cutting-edge initiatives and investments where healthcare and information technology intersect. 

This webinar is for market access recommenders and decision makers in biopharma companies.