Republican senators are calling on the Department of Health and Human Services to release documents that would let the medical industry bring generic vaccines and tissue products to market.
Medical products made from living cells such as vaccines and skin grafts are known as biologics, and their generic versions are called biosimilars.
“The [Food and Drug Administration] has not yet issued guidance on some of the key scientific policy questions related to biosimilars, such as naming, labeling, indication extrapolation, and interchangeability,” Sens. Orrin Hatch (R-Utah) and Lamar Alexander (R-Tenn.) wrote in a letter to Health and Human Services Secretary Sylvia Burwell.
“We urge you and those within your Department to immediately release guidance pending within the HHS related to the implementation of the biosimilar pathway,” they added.
Biosimilars have been in wide use in Europe and according to Express Scripts, the largest pharmacy benefit management company, their wider use could save the U.S. healthcare system more than $250 billion in the next few years.
Last week the FDA said it was reviewing Sandoz’s biosimilar Zarzio, which could reduce infections in cancer patients. If approved, it would be the first biosimilar to hit the U.S. market and open the floodgates for similar products.
“We assume that FDA and Sandoz had conversations about key issues … and that the FDA is engaged in conversations with other manufacturers who intend to file biosimilar applications in the future,” the two GOP lawmakers wrote.
They noted the FDA is required to release guidance to industry under the 2010 Biologics Price Competition and Innovation Act (BPCIA) but has yet to do so.
“These meetings should not be the only or primary means by which BPCIA implementation policies are developed,” they added. “Does the FDA intend to approve the first biosimilar before policies on these key scientific questions are publicly released?”
Sens. Richard Burr (R-N.C.), Mike Enzi (R-Wyo.) and Pat Roberts (R-Kan.) also signed the letter.