WASHINGTON, April 16, 2015 /PRNewswire-USNewswire/ — United Spinal Association, a national organization dedicated to enhancing the quality of life of all people living with spinal cord injuries and disorders (SCI/D), today urged Congress to hold oversight hearings to ensure FDA prioritizes safety for biosimilar medicines. Biosimilars are highly similar, but not identical, to biologic medicines. They are not generic copies of biologic medicines.
“The potential arrival of biosimilars to the market holds the promise of new therapies for individuals living with SCI/D, but safety cannot be compromised in the name of regulatory expediency,” said United Spinal President and CEO Joe Gaskins.
“To date, there have been no Congressional hearings on biosimilars and the FDA has yet to issue final guidance on a range of key patient safety issues,” added Gaskins.
United Spinal believes that biosimilars should:
The FDA approved the first biosimilar in March and several other applications are currently under review. The FDA has not yet issued guidance documents on biosimilars, however, leaving significant questions unanswered about how these new drugs will come to market.
“We urge Congress to schedule oversight hearings to ensure the voice of our members and the broader disability community is heard as the FDA approves biosimilars,” stated James Weisman, United Spinal Association Executive Vice President and General Counsel.
“The FDA must make good policy from the outset when approving biosimilars. A one-size-fits-all approach to approving biosimilars is unacceptable,” said Weisman.
