House Bill Takes Aim at Barriers to Biosimilar Substitution

While the United States has an increasing number of approved biosimilars, uptake of these less costly alternatives to biologics has been uneven and slow. A new bill introduced in the House of Representatives seeks to evaluate the current challenges to substituting biologics with biosimilars with the purpose of making biosimilars more accessible.

The Biologics Competition Act of 2022 (HR 887) was introduced by Representatives Mariannette Miller-Meeks, MD, R-Iowa; Greg Murphy, MD, R-North Carolina; Nanette Barragán, D-California; and Ann Kuster, D-New Hampshire.

“As pharmaceutical prices continue to skyrocket, we must do everything in our power to make lifesaving drugs more affordable for those in need,” Miller-Meeks said in a statement. “Our bill will encourage the Department of Health and Human Services to expedite the approval process for biosimilar products which may be used interchangeably in place of more expensive drugs.”

There are currently 38 biosimilars approved in the United States, although only 22 have launched so far. The biologic with the most approved biosimilars is adalimumab (Humira); however, none of these have launched yet due to settlement agreements. The first adalimumab biosimilar will reach market in January 2023.

Of the approved biosimilars, there are 3 with interchangeability status, which means the product may be substituted for its reference product without intervention of the prescriber. A biosimilar with interchangeability is not any more effective than a biosimilar without the designation, although that is a source of confusion and an area of necessary education for health care providers.

The bill directs the secretary of HHS within 1 year if the bill is passed into law to complete a study evaluating how substitution of interchangeable biologic products may be impeded. A report will be submitted to Congress on the results of the study.

In addition, HHS is directed to update the list published in the Purple Book. The Purple Book is a searchable, online database that contains information about biological products updated by the FDA for users to see if biologic products have been deemed biosimilar to or interchangeable with a reference biologic product.

The update to the Purple Book should align communication of substitutability of interchangeable products with communication about therapeutic equivalence ratings, according to the text of the bill.

“At a time when Americans are struggling to afford the escalating prices for prescription drugs, bureaucracy can’t get in the way of Americans accessing life-saving medicines,” said Barragán. “I am proud to join Reps. Miller-Meeks, Murphy, and Kuster in working to make biosimilars more accessible and affordable to the American people. Our bill will make HHS take a closer look at the unnecessary hurdles that delay access to innovative biosimilars and report back to Congress. Interchangeable biologics can reduce drug costs, and this bill takes an important step forward to ensure they are accessible to patients.”