As the February 4th FTC workshop on follow-on biologics approaches, here’s another VIP (Very Important Perspective) that the Commission has chosen not to bring to the public. Today’s VIP is a physician with experience prescribing and treating patients with biologics. Dr. Bert Petersen, a surgeon, is director of the Breast Surgery Clinic of St. Barnabas Hospital in New York City and an adjunct associate professor of surgery at New York University School of Medicine. Dr. Petersen is an advocate for the elimination of health disparities, particularly in terms of cancer and chronic diseases. Here are his thoughts on why the biologics naming issues matters for both him and his patients.
Q: What role do biologics play today in treating patients?
A: In my field, cancer – specifically breast cancer, we’ve seen great success in treatment for early and advanced stages with biologics. As we move toward more targeted therapies for chronic disease, they play an increasingly important role.
Q: Do you think there may be certain populations who are more at risk to an immunologic response from a biologic?
A: Yes. Any populations that may have a compromised immune system—specifically, many patients with chronic disease—can be impacted. These include at risk populations such as the elderly, immune deficient and chronic renal disease patients, etc. Additionally, at-risk populations tend to be patient populations that may lack quality insurance or access to healthcare. Furthermore, many of these chronic diseases disproportionately impact the poor. This makes access to biosimilars even more important for this population
Q: What value could biosimilars offer patients?
A: Two of the biggest reasons to look at biosimilars are cost and access. Can we offer the same effective treatment while controlling cost? My biggest concern is how we increase equal access to quality health care. We want to increase our reach in expanding healthcare, but it must be quality health care. Biosimilars offer a chance to meet the goals of affordable and quality treatment options.
Q: What is your view on the best approach FDA could take on biologics naming and how does distinguishable naming help keep our biologic supply safe?
A: Unlike any other field, medical decisions must be met with great scrutiny and thoughtfulness because any mistakes or missteps can be fatal. Patient safety should be the FDA’s overarching principal when it comes to approving biosimilars and any other drug.
In terms of distinguishable naming, I believe that biosimilars definitely should have different names, so you can determine if drugs are equal in their effectiveness. In my opinion, it’s unethical to treat patients with something pretending to be something else when it may or may not be. It’s also unsafe. I have a real problem with this as a practicing physician who treats patients with life threatening illnesses.
Q: Why is it important for patients and doctors to know what biologic is being, and has been put into, a patient’s body?
A: Much of how we practice is based on evidence-derived medicine. This is how we gather our evidence to know what is effective and what is not. Understanding which biologics patients have used will help us as we move toward the future to make any modifications that are found necessary.
Q: What impact would distinct naming have on trust in biosimilars?
A: I think if we could distinguish drugs, providers would have less hesitation in prescribing them. If providers are more educated and they have a clear pathway to report adverse effects—they would be more motivated to trust and prescribe biosimilars.
Thank you, Bert
