On January 10, 2019, the Washington Post published an article “Patients stuck in corporate fight against generic drugs.”  I spoke extensively with the author of the article and also suggested that he speak with the Chair of the Alliance for Safe Biologic Medicines (ASBM) international advisory board Dr. Philip Schneider.  Unfortunately, the article did not represent the information that was shared by me and Dr. Schneider about the work of ASBM.  Instead it attempted to portray ASBM as an organization seeking to “create confusion about the safety and effectiveness of unbranded biologic drugs” which is an assertion that cannot be credibly made in light of ASBM’s record.


Since 2013, ASBM has been involved in efforts to pass state legislation that is intended to increase access to biosimilars by allowing pharmacists to automatically substitute interchangeable biosimilars once approved by the FDA without consulting with the prescribing physician–provided the physician is notified within 72 hours.  This legislation is consistent with the position of the FDA and removes the prior authorization or notification barrier that can delay access to biosimilars.  We have provided testimony either in written form or in-person in each of the 45 states where these laws have been passed.


ASBM has, from its inception in 2010, been focused on serving as a resource for regulators and policymakers in order to help establish a robust biosimilars program that will ultimately increase access and reduce the cost of medicine for patients and governments worldwide.  I have served as the Executive Director of ASBM since it was formed. Our focus on affirmatively establishing – not thwarting – a pathway for biosimilars, including substitution when appropriate – was built on my experience in government, including three tours at the U.S. Department of Health and Human Services (HHS) under the 41st, 42nd and 43rd Presidents.  I served my final tour at HHS working in the Office of the Secretary from 2002 to 2008 and know from firsthand experience how important thoughtful participation by informed experts is to sound public policy.


Since 2010, ASBM has participated in more than 50 meetings with regulators worldwide to discuss policy issues and challenges around biosimilars.  In every instance, ASBM has begun with the underlying and fundamental assertion that biosimilars are an important tool in the attempt to increase access and reduce the cost of medicines.  We have provided in-person testimony to the FDA on at least 15 occasions during that time. I have participated on panels discussing biosimilar policy with regulators in Berlin, Brussels, Canberra, Dublin, Geneva, Madrid, Ottawa, Paris, and Rome and met directly with senior government officials from the European Commission (Brussels), European Medicines Agency (EMA), FDA, Health Canada, Italian & Spanish Ministries of Health, Therapeutic Goods Administration (TGA) and World Health Organization (WHO).  We have conducted 14 physician surveys in 12 countries and shared the results of those surveys directly with the regulators in the countries surveyed. All of the surveys are publicly available on our website www.safebiologics.org/surveys.


ASBM will continue to serve as a resource for policymakers and regulators in the U.S. and across the globe as they attempt to build a robust and sustained biosimilars program that will benefit patients worldwide.
Michael Reilly
Executive Director, ASBM