The FDA wants doctors to know more about biosimilars

The FDA hopes wider use of biosimilars will help to curb high prescription drug costs.

The FDA wants to get information about biosimilars, which hold promise to curb prescription drug costs, into more physicians’ hands.

Everyone worries about healthcare costs, but price transparency tools for healthcare services have gained little traction. Now the focus is turning to prescription drug prices, as physicians and insurance companies embrace price controls such as wider use of lower-cost generic drugs.

The FDA's new educational program aims to raise the profile of biosimilars, another class of pharmaceuticals poised to generate price competition in the prescription drug market. Where generic drugs use the same active ingredient as a brand-name product, the FDA describes its approved biosimilars as “highly similar” products whose clinical effectiveness and safety equals that of an already-approved product.

So far, the FDA’s Center for Drug Evaluation and Research has approved seven biosimilars and the agency expects more to come, as it hopes the market competition produced by these new products will exert downward pressure on drug prices. “As with the significant savings that we’ve seen through the introduction of generic drugs in the United States, biosimilars could also lead to substantial savings, thereby potentially improving access and promoting better public health outcomes,” the agency said in a statement.

The first phase of outreach involves getting the word out on basic definitions that describe the relationship between a biosimilar and the product with which it is interchangeable, known as the “reference product.” Those definitions include FDA standards and a description of the approval pathway for biosimilars, as well as information about the FDA’s primary reference for this class of products, the Purple Book.

Once physicians are broadly familiar with biosimilars, the FDA’s next step will be to determine how to communicate information about the products to patients, so that they will understand the available options and be able to make informed choices.