Marc Inglese: Don’t sacrifice safety

Published: Friday, April 12, 2013 at 3:30 p.m.
Last Modified: Friday, April 12, 2013 at 3:30 p.m.

Lloyd Dunkelberger's April 6 story, “Battle over biosimilar drugs starts to heat up,” discusses the two sides being debated in Tallahassee as lawmakers determine how to substitute complex biologic medicines with biosimilars. While this article focuses on cost, we have to make sure that biosimilar policy is focused on patients.

I am in the practice of medicine to help my patients receive the best possible care. I am excited that biosimilars will soon be available to my patients at a lower cost, however, I do not want the possibility that their safety could be sacrificed in the process. Even the smallest difference in the structure of a biologic medicine and its attempted copy can have a significant impact on a patient, which is why physicians must be notified when one complex biotech drug is substituted for another. I cannot properly care for my patients if I do not know what medicine they are taking.

In the European Union biosimilars are available, but far from commonplace as the author suggests. There are currently 14 biosimilars available for use in the E.U., and automatic substitution by a pharmacist of a biosimilar is not allowed in any European country and is not recommended by the World Health Organization or by medical societies. As biosimilars become available in the U.S., we have to take every necessary precaution to ensure their safety and while I prefer the European approach of letting the doctor decide, at a minimum the doctor must be informed that a substitution has occurred.

Opponents of the legislation like to emphasize the savings that will occur if we leave the doctor out of the equation and let pharmacists or insurance companies decide whether a patient gets the biologic prescribed or a biosimilar. The difference between me and an insurance company or PBM is that my oath is to my patient and theirs is to their shareholders. Ultimately, it can appear that they are focused more on reducing the cost of care and not enough on the quality of care that is being provided.

When treating patients who are suffering from some of the most debilitating diseases we face -- including cancer, HIV, MS, rheumatoid arthritis, psoriasis and many others -- we have to ensure that the focus in on the quality of care and the safety of the patient first, and only when we have that assurance can we focus on reducing the cost of care.

Dr. Marc Inglese specializes in dermatological care for adults and children, as well as internal medicine. In addition to private practice, he is an assistant clinical professor of dermatology at the Florida State University College of Medicine.

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