Biosimilar drugs hold advantages for people like me, just as biologic medicines have for millions living with life-threatening and life-diminishing diseases. Access to appropriate medication can dramatically improve disease outcome and quality of life. As more biosimilars become available, we want to ensure they are safe and affordable. I strongly support S6311 and A8648A, which will create a new pathway for biologic substitution where none exists in New York.
Our immune response to treatments is unique and at times adverse. Since biosimilars are not precise replicas of the originator biologic and autoimmune patients are so hypersensitive that even the slightest change in manufacturing, dose or method of delivery can provoke an immune response and disease complications, patient safeguards must be established.
This legislation ensures the treating physician is aware of the exact biologic product, indicated by manufacturer, given to a patient in order to facilitate care and accurately attribute any adverse events.
Pharmacist-prescriber communication is paramount in identifying exactly which medicine was received if an adverse event occurs because biosimilars will be administered to individuals suffering from serious, life-threatening diseases.
S6311 and A8648A will facilitate communication between pharmacists, prescribers and patients. This legislation is timely given the U.S. Food & Drug Administration’s approval of the first two biosimilars and additional products in the pipeline. More than 20 states and Puerto Rico have already passed biosimilars legislation. It is imperative that these safeguards are put in place in New York state to provide the best medical care possible and that patients have access to life-changing therapies. I urge state legislators to support these bills.
Kathleen A. Arntsen
President and CEO,
Lupus and Allied Diseases Association Inc.