5 Myths About Biosimilars-And the Facts

April 15, 2019

The falsehoods being spread about biosimilars that don’t match up with reality.

Biosimilars are poised to save U.S. healthcare billions of dollars, but so far uptake has been slow-only 18 have been approved, and of those 18 only seven are on the market.

The reasons for this are complex, from patent disputes to naming issues to a lack of development. But one major issue has been a variety of myths surrounding biosimilars and their efficacy. These are 5 of the biggest myths about biosimilars-and the actual truth about them.

Christine Simmon, executive director at The Biosimilars Council, says some payers and providers are waiting for interchangeable products rather than using biosimilars now. Interchangeable products are biosimilars with added approval requirements which can be substituted for a reference product without prescriber involvement. However, she says, not only are they going to have a long wait (there are currently no approved interchangeable products, and few manufacturers are willing to go through the extra steps), but interchangeable products do not confer any quality attributes that make them better than biosimilars.

Some say that biosimilars are not as effective as reference biologic products. However, The Biosimilars Council says that, beyond the academic and clinical testing showing their safety, Europe has been using biosimilars for over a decade in real-world scenarios without any significant difference in efficacy shown between biosimilars and reference products.

Last month, the FDA issued new naming guidelines for biosimilars, mainly surrounding the addition of a 4-letter suffix to biosimilar drugs-but not to the originator. The agency claims the guideline will allow for more vigilant tracking of biosimilars. Simmon says that this creates a myth that a suffix improves patient safety. She says that this is “patently untrue.”

The Biosimilars Council argues that it gives patients and prescribers the idea that biosimilars are the only biologics that require constant monitoring-not the originators.

Some believe that biosimilars are not as safe as reference products. However, according to The Biosimilars Council, biosimilars undergo rigorous FDA testing, review, and safety monitoring. The FDA also requires that the route of administration, dosage form, and the strength of the biosimilar and reference product must be the same.

Because there are so few biosimilars currently on the market, some believe that costs savings won’t develop from their use. However, Simmon says that biosimilars are launching with a significant discount to their reference products. This could allow for significant savings because, according to The Biosimilar Council, while biologics are only used by 2% of Americans, they account for 40% of prescription drug spending in the U.S.

Estimates vary, but all told this could lead to savings of up to $250 billion over the next decade.