Hello patient advocates! Dr. Angus Worthing here, the new chair of the American College of Rheumatology (ACR) Government Affairs Committee! As a practicing rheumatologist in the Washington, D.C. area, I have over a decade of experience treating patients while actively participating in public policy. In addition to my involvement with the ACR, I am also the chair of the Public Policy Education Committee of the Rheumatism Society of the District of Columbia.
This year, I look forward to working with our rheumatologists and patient advocates to ensure rheumatology patients have access to affordable, effective, and safe healthcare. We are actively engaging on a number of issues related to that goal, one of which involves the regulation, marketing, and prescribing of biosimilar therapies.
As you may know, biosimilars are comparable versions of biologic therapies that have the potential to lower the cost of these life-changing – yet very expensive – therapies. In November, the first biosimilar to treat rheumatic diseases will hit the U.S. market and a handful of other biosimilar therapies intended for the treatment of rheumatic diseases have either been approved or are currently undergoing U.S. Food and Drug Administration (FDA) review.
The addition of new and potentially lower-cost therapies is good news for patients who struggle to access and afford the biologic therapies they need to manage their conditions, as well as for the efficiency of the overall U.S. healthcare system.
But it is also important that we proceed with full transparency as we bring new biosimilar therapies to market. These drugs are highly complex and even small changes to them can have huge implications for patients. As new biosimilars are approved and prescribed, it is critical that doctors have as much information about these therapies as possible so they can make the right care decisions for patients.
In the coming months, we’ll be working on a number of efforts to ensure that new biosimilars are introduced to the healthcare system as safely and quickly as possible. These efforts include:
- Encouraging the FDA to adopt guidance that requires distinct naming and transparent labeling for all biosimilar products.
- Requiring pharmacists to provide adequate notification to patients and prescribing doctors when substituting a biosimilar therapy for the prescribed biologic therapy.
- Asking Congress to provide funding to enhance and expedite the FDA’s review of biosimilar therapies.
- Encouraging insurance and pharmacy benefits companies not to force patients to switch from a biologic to a biosimilar when the biologic is working well.
We have a lot of work to do, and I look forward to keeping you updated on our progress and working with our patient advocates in the coming months!
Dr. Angus Worthing