A bipartisan bill sponsored by U.S. Rep. Mariannette Miller-Meeks (R-IA) aims to speed up the approval process for less expensive biosimilar drugs, making them available more quickly and expanding access to affordable, life-saving medications.
“As pharmaceutical prices continue to skyrocket, we must do everything in our power to make life-saving drugs more affordable for those in need,” Rep. Miller-Meeks said. “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.”
The Biologics Competition Act of 2023, H.R. 1790, which Rep. Miller-Meeks introduced alongside three original cosponsors, including U.S. Rep. Nanette Barragán (D-CA), would direct the U.S. Secretary of Health and Human Services (HHS) to evaluate the process by which interchangeable biological products are approved to be used in pharmaceuticals, according to a summary provided by the lawmakers.
“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 Rep. Barragán. “Our bill will make HHS take a closer look at the unnecessary hurdles that delay access to innovative biosimilars and report back to Congress.”
Currently, the Food and Drug Administration approves generic drugs and biological products differently. When a generic drug is approved, it is assigned a therapeutic equivalence rating; a biological product is designated as “interchangeable,” which creates uncertainty among pharmacists, according to the bill summary.
If enacted, H.R. 1790 would require HHS to conduct a study on the approval process of interchangeable biological products to ensure they are available to pharmacists in an efficient manner, the summary says.
The measure has been referred for consideration to the U.S. House Energy and Commerce Committee.