Understanding the Challenges Surrounding Uptake of Biosimilars

During the NAMCP Spring Managed Care Forum 2017, Steven Feldman, MD, PhD, of the Wake Forest University School of Medicine broke down the challenges associated with biosimilar adoption and provided strategies for overcoming barriers to utilization.

Dr Feldman started by outlining how the safety and efficacy of biosimilars compare to that of their reference products. He explained that while biosimilars are very close duplications of their reference product, they are not exactly the same, which can cause uncertainty for patients, providers, and payers. According to his presentation, providers are very comfortable with generics but remain uncomfortable with biosimilar products.

He cited evidence that showed that biologics have great efficacy and great safety—but are increasingly expensive—usually priced in the $20,000 to $60,000 per year of treatment range.

Dr Feldman showed evidence that highlighted how biosimilars do not get the exact same results as their reference product, but are usually statistically insignificant, and count as equivalent efficacy.

During the end of his presentation, Dr Feldman posed a few hypothetical questions in order to explain the state of the biologic vs biosimilar argument.

He asked “should we be comfortable with a biosimilar that is not identical to the original drug,” and “is it acceptable to switch patients from originator to biosimilar without our notification?”

Dr Feldman stated that the answer to these questions should be “no,” because we already do these things with the reference product alone. He explained that no 2 batches of an innovator product are exactly the same on a molecular level, and therefore, we are giving different patients different versions of the drug already.

“Biosimilars will give us even more data—far more data—to support being comfortable than we have now,” Dr Feldman concluded. —David Costill