With the backing of new laws, retail pharmacists have considerable freedom to switch patients to FDA approved interchangeable biosimilars. While most are willing to use that freedom, according to a new report, unanswered questions remain.
Scientific Rigor is Required
The vast majority – 91% – of pharmacists surveyed said they are “very comfortable” or “somewhat comfortable” substituting an interchangeable biosimilar for its reference biologic.
Despite their willingness to make the substitution, one-third of pharmacists expressed uncertainty about the efficacy of biosimilars. That concern could fade, though, as pharmacists become more familiar with the FDA’s rigorous approval process for biosimilars. In fact, seven in 10 pharmacists indicated “biosimilar 101 materials” and biosimilar product fact sheets would be useful.
The federal agency requires proof that a biosimilar is as safe and effective as its reference product, and that it has no clinically meaningful difference, before designating it an “interchangeable biosimilar.” Federal approval, in effect, means patients can expect the same treatment outcome whether they use a biologic or its interchangeable biosimilar.
There is currently only one interchangeable biosimilar on the market and one other that has been approved, but additional approvals are expected soon. As more interchangeable biosimilars become available, pharmacists may substitute more often.
The Benefits of Biosimilars
Biosimilars provide more treatment options, according to groups like the Biologics Prescriber’s Collaborative, and they have the potential to reduce patients’ out-of-pocket costs.
The pursuit of cost savings shouldn’t drive all decisions, however. Patient and provider preferences must be considered – only after head-to-head trials prove no meaningful differences in outcomes between the two treatments.
Patients and providers should have access to the full range of approved therapies as they work in partnership to create a treatment plan.
More Education is Key
Retail pharmacists are an invaluable and accessible resource for helping the public with medication questions. Now is the time to answer their calls for more education about the effectiveness and benefits of biologics, biosimilars, and now interchangeable biosimilars so more patients can reap the medications’ benefits too.