United Spinal Urges Congress to Hold Oversight Hearings on Biosimilar Medicines to Ensure FDA Prioritizes Safety
Disability Community Calls for Consumer Safeguards and Guidance from FDA for New Category of Biologic Drugs
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:
- Have non-proprietary, distinguishable names to facilitate accurate and prompt identification in case of an adverse event.
- Have a label that designates the product as a biosimilar.
- Have strict standards for interchangeability -- meaning that the biosimilar must produce the same clinical result as the reference product in any given patient and switching between the biosimilar and innovator biologic presents no greater risk in terms of immunogenicity, safety, or reduced efficacy than continued use of the innovator biologic.
- Have undergone rigorous clinical testing to prove that a biosimilar is effective and safe in each and every condition or disease which it is approved to be prescribed.
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.
About United Spinal Association
United Spinal is a national 501(c) (3) nonprofit membership organization formed in 1946 by paralyzed veterans and is dedicated to improving the quality of life for all Americans with spinal cord injuries and disorders (SCI/D), including multiple sclerosis, spina bifida, ALS and post-polio. It played a significant role in writing the Americans with Disabilities Act, and made important contributions to the Fair Housing Amendments Act and the Air Carrier Access Act. Membership is free and is open to all individuals with SCI/D. United Spinal was instrumental in getting New York City to create sidewalk curb ramps and accessible public transportation that has been used as a model for many United States cities.
SOURCE United Spinal Association
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