Debate continues about how biosimilars that are emerging to treat rheumatic diseases will be named and monitored, said panelists at a recent meeting in Washington, D.C.—Biosimilars in the United States: Next Steps.
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Angus Worthing, MD, FACR, FACP, a member of the ACR’s Government Affairs Committee, shared rheumatologists’ concerns as these new therapies come to market. And it’s an urgent debate: a biosimilar to Remicade (infliximab), called Inflectra (infliximab-dyyb), was approved by the Food and Drug Administration (FDA) on April 5. And two more are on the horizon: The FDA’s Arthritis Advisory Committee met and reviewed proposed biosimilars for etanercept and adalimumab in July, voting unanimously to approve them.
“Right now, we have a lot of confidence that the FDA will give us good information on these products’ safety and efficacy,” said Dr. Worthing. “Full transparency about biosimilars is [needed in order] for everyone to be confident about using these therapies to treat rheumatic diseases. Patients need to know what they’re taking, and physicians need to know what they’re prescribing. This can be accomplished by using distinct names for biosimilars, having clear information on FDA drug labels and implementing consumer-oriented pharmacy dispensing practices.”
Drug Naming & Substitution Concerns
Prescribers still control drug substitution at this point, because no manufacturers have applied for interchangeable status yet. There’s a higher standard of proof involved when the drug is so similar to the reference product that it could be substituted by the pharmacy like generic drugs are, something that concerns rheumatologists, according to Dr. Worthing. Pharmacy notification of biosimilar substitution to prescribers is something rheumatologists strongly support, he said.
“We currently do not know what may happen when switching a patient back and forth between a biosimilar drug and its original reference product,” he continued. Some patients could become immune to the new biosimilar, as well as the original biologic drug, he said. “This may cause the drugs not to work or even cause allergic reactions, which is why it’s incredibly important that we protect patients against forced switching between biologics and biosimilars by insurance companies and pharmacy benefit management companies.”
When a patient’s condition is well controlled or in remission on one agent, changing products may not be in the patient’s best interest.
The FDA Steps In
The FDA has issued draft guidance documents on naming and labeling to gather opinions on future regulations, said panelist Leah Christl, PhD, the FDA’s associate director for therapeutic biologics. It is also investing in professional and patient education campaigns, and has created the Purple Book, an online biosimilars resource for prescribers.