As a physician, I have seen the difference biologic medicines have made for patients suffering from skin disease, cancer, multiple sclerosis and rheumatoid arthritis. Treatment with biologics is extending and improving lives and providing a way to manage diseases like never before. Equally good news is that on the horizon are biosimilars, or “copies,” that are highly similar, although not exact, versions of the original biologic. This is worthy news for patients because it will make safe and presumably lower-cost alternatives readily available.
While the U.S. Food and Drug Administration will make scientific decisions on whether to approve a biologic, including whether it is so similar as to be deemed interchangeable with the original product, it is state law that determines under what circumstances an interchangeable biosimilar may be substituted.
The Pennsylvania Senate recently passed legislation that would update pharmacy laws and establish the necessary treatment of the substitution of biosimilars. Physicians would maintain the right to make sure their patients receive the best treatment, while pharmacists would be able to provide lower-cost alternatives. Timely communication between the pharmacist and the physician would be fostered to maintain complete and accurate medical records. In addition, a robust system of reporting, tracking and tracing any adverse events also would maintain patient safety and hold manufacturers responsible for their products.
I call upon the Pennsylvania House of Representatives to take the necessary steps to facilitate Pennsylvanians’ access to biosimilar medicines through appropriate substitution policies.
MARK P. SERALY, M.D.