The section of the Affordable Care Act, which calls for the creation of the biosimilar pathway, was recently upheld by the Supreme Court. While not as headline-worthy as the news surrounding the individual mandate, the fact that the Biologics Price Competition and Innovation Act (BPCIA) provision survived the process was significant for the biotech world.
Biologics are some of the best treatment options for serious medical conditions such as cancer, autoimmune diseases, and Alzheimer’s. Unlike traditional chemical drugs, biologics are made from living organisms and are significantly more complex.
Generic versions of chemically produced drugs have existed in the United States since the 1980’s, but copycat forms of biologic drugs are currently unavailable. In 2010 Congress tasked the Food and Drug Administration (FDA) with creating an approval pathway for the sale of biosimilar versions of biologic medicines in the United States, as part of the Affordable Care Act.
Although I believe that many parts of the Affordable Care Act are bad and will weaken care in the United States, the FDA’s ability to approve biosimilars will foster investment, ensure patient safety, expand patient access to biotech medicines. Most importantly, the FDA will continue its work to develop a regulatory pathway for safe and effective use of biosimilars.
One challenge for regulators remains patient safety. Because biologics are made from living organisms, biosimilars can only be similar to their innovator product, never identical. Consequently, these copycat drugs can present safety challenges above and beyond traditional chemical drugs.
Any small difference in the structure or makeup of a biosimilar may cause serious side effects, if not properly regulated. Therefore, the FDA cannot take shortcuts. The FDA should include robust clinical testing for biosimilars, unique product names, labels and codes, as well as a means to track and trace these advanced medicines. Additionally, requiring a tracing system will make it easier to identify and remove a faulty product from the pharmacy shelves and medicine cabinets.
Moving forward, the FDA must take into consideration all the possible safety risks. For instance, allowing for a biosimilar to be exchanged for its biologic counterpart could cause severe safety consequences for the patients and could also take the health care decision making process out of the hands of patients and physicians and into the hands of insurers. In addition, allowing pharmacists to provide biosimilars to patients who have been prescribed biologics can be dangerous due to the vital differences between biologics and their imitators. If patients are to be properly protected, federal and state lawmakers across America must ensure that switches of this kind are never made without the prescribing physician’s knowledge and consent.
As a long time patient advocate and surgeon, I know that the decision for health care should always be in the hands of qualified medical professionals and their patients. And, with the creation of biologic and biosimilar medicines standing out as some of the most important health care developments of our time, the FDA must work to ensure that these drugs continue to be held to the highest standards that protect patients from harm.
Donald J. Palmisano is the former president of American Medical Association and is Clinical Professor of Surgery and Clinical Professor of Medical Jurisprudence, Tulane University School of Medicine.
