April 13, 2015
The Honorable Jerry Hill
State Capitol, Room 5035
Sacramento, CA 95814
Dear Senator Hill,
As the chairman of the Alliance for Safe Biologic Medicines (ASBM), I am writing to
express our support for SB 671. This patient focused and commonsense legislation
authorizes pharmacists ‘to select an alternative biological product when filling a
prescription order for a prescribed biological product if the alternative biological
product is interchangeable, as defined, and the prescriber does not personally
indicate “Do not substitute”.’ Most importantly, SB 671 will facilitate consumer
knowledge and communication between pharmacists and physicians when
“interchangeable” biosimilars are substituted for a prescribed biologic. This
legislation is especially important in light of the U.S. Food and Drug Administration’s
(FDA) March 6, 2015 approval of the first biosimilar in the U.S.
ASBM is an organization of patients, physicians, pharmacists, biotechnology
companies that develop innovative and biosimilar medicines and others who are
working together to ensure that patient safety is at the forefront of all biosimilar
policy discussions. Since our origin in 2010, ASBM and its associated members and
collaborators have been leaders on the issues unique to biosimilars in the United
States and internationally. Our combined experiences and evaluations have led to
the development of key principles we believe should be included in any formal
policy recommendation regarding biosimilars. We invite you to review these
principles as well as additional information on our website.
As you know, biologics are highly complex, advanced prescription medicines used to
treat cancer, rheumatoid arthritis, diabetes, MS and an increasing number of other
debilitating diseases. They have been hailed as miracles by physicians and patients
alike with these and other serious illnesses. Unlike drugs derived from chemicals,
biologics are manufactured using unique processes with living cells; therefore,
biologics made from different cell lines can never be identical. When a company is
attempting to replicate a biologic medicine, their “copies,” known as biosimilars, can
only be similar to, but never exactly copy the originator versions of the biologic
medicine. Being much smaller molecules, chemical medications can be more closely
copied resulting in "generic" equivalent medications and cause less variation in
effect when interchanged. The frequent reference to biosimilars as “generics" is
therefore an inaccurate and incorrect comparison, since even the smallest difference
between the structure of a biologic medicine and its attempted copy can have a
significant and potentially permanent impact on a patient. It is this complexity and
the potential significant consequences, both positive and negative that make this
issue of interchangeability and notification an important new challenge for
policymakers. We are pleased your proposed legislation addresses these issues in a
manner that promotes patient safety and increased collaboration by all members of
the patients’ health care team.
ASBM has been working with physicians and pharmacists for the past 4 years to
help identify, formulate and implement the best approaches to ensure the safe
introduction and monitoring of biosimilars in the United States as well as
internationally. We have been holding forums and meetings with policymakers,
patient advocates, physicians, pharmacists and other stakeholders across the
country to discuss and educate the policy challenges associated with these nextgeneration medicines and the accompanying need for stringent manufacturing and
notification standards to ensure patient safety and improved health.
Specifically, ASBM believes appropriate regulations are needed to ensure doctors
and other prescribers know what medicines are actually dispensed and
administered to their patients. Physicians and pharmacists should work
collaboratively in order for the safety and well-being of patients remains the top
priority. It is therefore necessary for physicians to be informed in a timely fashion
of the exact biologic – by manufacturer – their patient receives in order to accurately
assess the medication's efficacy as well as more precisely attribute any adverse
events that may occur.
We have performed multiple surveys demonstrating significant gaps in the
knowledge about biosimilars among physicians, pharmacists and patients. For
example, ASBM just released a new survey on labeling revealing that physicians who
prescribe biologics support transparent, clear labels with data that enables
prescribers and their patients to more fully understand and evaluate the medicines
being prescribed. The resulting enhanced communication between patients,
pharmacists and physicians will improve the safety, efficacy and appropriate use of
biologic products, both originators and biosimilars, producing more and better
treatment options for these serious and chronic diseases. To further this goal, Dr.
Philip Schneider, chair of our International Advisory Board and Associate Dean at
the University of Arizona College of Pharmacy led a continuing education course at
the Long Island University College of Pharmacy on March 15, 2015 entitled “The
Fundamentals of Biosimilars: What Every Pharmacist will need to Know” discussing
these issues. Ronald Jordan, Ph., FAPhA, the founding dean of Chapman University in
Orange County and I also participated and we are working together to host a similar
event in Irvine next month.
We have strongly supported the FDA and other regulatory bodies around the world
on the creation of biosimilar policies that keep patient safety at the forefront. We are
proud to similarly support you and your efforts in making patient safety a priority
for all citizens of the Golden State.
Please feel free to contact me on my personal cell at (804) 307-6896, or the ASBM
executive director, Michael Reilly (Michael@safebiologics.org/202.222.8326), if you
have any questions or if we can be of any additional service to you in promoting this
important legislation.
Sincerely,
Harry Gewanter, M.D.
Chairman, The Alliance for Safe Biologic Medicines
Members:
Alliance for Patient Access
American Academy of Dermatology
American Autoimmune Related Diseases Association
Association of Clinical Research Organizations
American Council on Science and Health
Amgen
American Association of People with Disabilities
Association of Black Cardiologists
Association of Gastrointestinal Motility Disorders, Inc.
BIOTECanda
Biotechnology Industry Organization
Colon Cancer Alliance
Colorectal Cancer Coalition
EuropaBio
Genentech
Global Colon Cancer Association
Global Healthy Living Foundation
Health HIV
Interamerican College of Physicians and Surgeons
International Cancer Advocacy Network
Kidney Cancer Association
MANA
National Hispanic Medical Association
National Alliance on Mental Illness
National Psoriasis Foundation
RetireSafe
ZeroCancer