As a treating physician who also serves as the Chairman of the Alliance for Safe Biologic Medicines (ASBM), I have been watching with great interest as the Food and Drug Administration (FDA) begins to unveil the approach it will take to bring “biosimilar” medications to the US. Biosimilars are attempts to replicate brand name biologic medicines. But as the name indicates, they are similar to them but not identical. Interestingly, when you look up the definition for “identical” in the dictionary it reminds us that it means to “have such a near similarity or resemblance as to be essentially equal or interchangeable.”
The law that granted the FDA the authority to approve biosimilars in the U.S., also gave the agency the authority to determine if a biosimilar is interchangeable with the brand name biologic it seeks to replicate. The concept of interchangeability is troubling to many practicing physicians, and I am one of them.
While further guidance is forthcoming from the agency, it initially signaled that manufacturers looking for their products to be deemed interchangeable should be prepared to provide more data and additional clinical trials at a minimum. These early signs combined with the FDA’s tradition of making patient safety its top priority should give treating physicians a great deal of comfort with regards to biosimilars. However, what happens at pharmacy counters across the country once a biosimilar is deemed interchangeable is cause for concern. This is because it is unclear whether states will allow pharmacists to automatically substitute biologics for interchangeable biosimilars without consulting the prescribing physicians or even notifying them.
States already have the ability to give pharmacists the right to automatically substitute generics for conventional brand name drugs but extending this policy to biologics and biosimilars fails to acknowledge the differences between generics and biosimilars. Generics are exact copies of small molecule brand name chemical medicines made in a lab using chemical reactions and chemical compounds. Biosimilars, however, are very large complex molecules that can only be made in a process more akin to molecular farming than chemistry. They are made from living cells with all of their intrinsic variations and cannot be made by chemistry alone. It is these differences that lead me to conclude that there is much more we need to learn about biosimilars before we can be confident enough in them to leave the treating physician in the dark when a patient is switched from a biologic to a biosimilar.
Doctors must be involved in any drug substitution process involving biologics – or at least be notified if it occurs. I believe if we chart this course that future generations of patients who reap the benefits of these drugs will be glad that we placed an emphasis on safety when we did. The difference between biologics and biosimilars is important enough to be centered in the doctor’s office, not at the pharmacy.
Richard Dolinar is an endocrinologist and Chairman of the Alliance for Safe Biologic Medicines, an organization to ensure patient safety is at the forefront of the biosimilars policy discussion.
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