February 2, 2015
The Honorable Pamela R. Lampitt
1101 Laurel Oak Rd., Suite 150
Voorhees, NJ 08043
Dear Assemblywoman Lampitt:
As the chairman of the Alliance for Safe Biologic Medicines (ASBM), I am writing in
support for A2477, biosimilar legislation that prioritizes patient safety.
ASBM is an organization of patients, physicians, pharmacists, biotechnology
companies that develop innovative and biosimilar medicines and others who are
working together to ensure patient safety is at the forefront of all biosimilar policy
discussions. We believe it to be critical that when interchangeable biosimilar
products are available, a strong communication and collaboration system is already
in place among patients, pharmacists, prescribers and regulators as a means to
facilitate the patient-centered medical home and limit potential errors and adverse
events. Direct and timely communication among patients, pharmacists, and health
care providers is essential to all patient care and is especially important given the
seriousness of the conditions being treated with biologic medication. A2477 will
help enhance patient safety in New Jersey by supporting the development of
appropriate regulations that consider and appreciate the unique and serious nature
of biologic medicines and the diseases they treat.
As you know, biologics are highly complex, advanced prescription medicines used to
treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating
diseases. Unlike drugs derived from chemicals, biologics are manufactured using
unique processes with living cells and for this reason biologics made from different
cell lines can never be identical. Therefore, 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.
Chemical medications can be more closely copied resulting in "generic" equivalent
medications; the frequent reference to biosimilars as “generics" is an inaccurate and
incorrect comparison. 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 consequences
that make this issue of interchangeability and notification an important new
challenge for policymakers.
ASBM has been working with physicians and pharmacists for the past 4 years to
help identify, formulate and implement the best approach to safely introduce
biosimilars to patients, both in the United States as well as internationally. ASBM
has 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 next-generation medicines and
the accompanying need for stringent manufacturing and notification standards to
ensure patient safety and improved health.
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 experiences and evaluations have led to the development of key
principles we believe should be included in any formal policy recommendation
regarding biosimilars. These principles can be found on our website.
Specifically, ASBM believes 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 showing a gap in the knowledge about
biosimilars among physicians, pharmacists and patients. It is clear that enhanced
understanding and communication between pharmacists and physicians will
improve the safety and efficacy of biologic products, while also advancing more
treatment options to patients. To further this goal, Dr. Philip Schneider, Chair of our
International Advisory Board and Associate Dean at the University of Arizona
College of Pharmacy will be leading 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” to discuss these issues.
The U.S. Food and Drug Administration (FDA) has begun accepting biosimilar
applications for review and is expected to approve the first biosimilar in the United
States within the coming months. We have strongly supported the FDA and other
regulatory bodies around the world on the creation biosimilar policies that keep
patient safety at the forefront. We similarly support you and your efforts in making
patient safety a priority for all citizens of the Garden State.
Please feel free to contact me personally, the staff or any of the members of ASBM if
you have any questions or if we can be of any additional service to you in promoting
this important legislation.
Sincerely,
Harry L. Gewanter, M.D., FAAP, FACR
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