WASHINGTON — RetireSafe, a grassroots organization advocating on behalf of America’s seniors on Tuesday released a survey finding that seniors overwhelmingly support strong patient safeguards for biosimilar medications. The survey comes as federal health officials prepare to release standards for the review and approval of biosimilars — medications that are highly similar but not identical versions of biologic medicines.
The survey of 1,467 RetireSafe supporters found that an overwhelming majority of respondents — more than 90% — did not know what biosimilar medications were or that the Affordable Care Act enabled the Food and Drug Administration to approve the use of biosimilars in the United States. The survey also identified support for patient safety protections, including requiring thorough testing of biosimilars prior to their approval and notification of patients and their physicians whenever a biosimilar is substituted for the original innovator biologic product prescribed.
“When it comes to new biosimilar drugs, people are rightly concerned and want to keep their drugs safe and effective,” stated Thair Phillips, RetireSafe president. “Seniors have made their voice clear that patient safety must come first if we are to reap the benefits of new lifesaving medicines. That is why RetireSafe is going to be calling on the FDA and elected officials to put in place a series of common-sense safeguards around new medicines in the form of a ‘Safe Medicines Bill of Rights.’”
Among the survey’s key findings:
- 92% wanted a requirement that drug companies test the safety of biosimilars for all conditions the drug will be used to treat;
- 86% wanted a requirement that drug companies that are developing biosimilars conduct human clinical trials to ensure a given biosimilar is safe;
- 90% believed that the name of the biosimilar should be different than the original biologic medicine to allow for adequate tracking of any adverse reactions;
- 91% want physicians to be notified when a biosimilar is substituted for the original biologic drug they prescribed for their patient; and
- 94% believe patients should be notified when a biosimilar is substituted for the original drug prescribed by their doctor.