Seniors to FDA: Safety in biosimilars

Biologics are truly miracle drugs. Made from living cells, they have revolutionized the treatment of multiple sclerosis, HIV, hepatitis C, rheumatoid arthritis and range of other diseases. While the introduction of biosimilar medications, which attempt to imitate cutting-edge biologic treatments, could be good news for patients who need more affordable treatment options, federal regulators also need to ensure that these new drugs are safely prescribed.

Officials at the Food and Drug Administration (FDA) are currently preparing to release standards for the review and approval of biosimilars, which may soon reach patients in the U.S.

The heart of the issue is that, unlike traditional medications which can generally be duplicated in generic form, the intricate organic make-up of biologics makes them impossible to replicate. So as we prepare for the introduction of biosimilar medications, the fact remains that these drugs, by their very definition, are not the same as the biologic treatments. As such, biosimilars could vary from biologics in both their safety and effectiveness.

More than 1400 supporters of RetireSafe recently responded to a nationwide survey to measure what older Americans know about biologics, biosimilars and the potential safety issues surrounding these new medicines.

More than 90 percent of respondents did not realize that, unlike generic treatments which are exact copies of chemical drugs, biosimilars can’t ever be generic versions of biologic drugs.

Upon learning more about biosimilars and the FDA’s current task of approving the use of these new medications, survey respondents expressed overwhelming support for patient safeguards.

More than 92 percent of seniors want drug companies to test the safety of biosimilars for all conditions they will be used to treat, and 86 percent want human clinical trials to take place.

And when biosimilars reach the marketplace, an overwhelming majority of seniors want safeguards to differentiate biosimilars from the biologic medications they are designed to imitate. In fact, 90 percent of seniors want each biosimilar product to have a different name than the original biologic so that patients and physicians can adequately track adverse reactions.

They also want to know exactly which medications they receive at the pharmacy. A full 94 percent believe patients should be notified when a biosimilar is substituted for the original drug prescribed by a doctor, and 91 percent want physicians to be notified whenever such substitution happens. 

Seniors are lending their collective voice to the chorus of Americans who want strong requirements to make sure that biosimilars are safely prescribed.

RetireSafe will be calling on the FDA and elected officials to put in place a “Safe Medicines Bill of Rights” containing common-sense safeguards for the introduction of biosimilars and other new medicines.

Seniors and other Americans battling diseases are often dependent on the medications they take. These patients and their physicians need to know if their treatment regimen is altered in any way.

Biosimilar products have the potential to join biologics and other lifesaving medicines that are extending and enhancing our lives, but patient safety must come first whenever new treatments are introduced.

FDA officials need to enact requirements that effectively differentiate biosimilars from biologics, while ensuring that both patients and physicians know exactly which drugs are dispensed at the pharmacy.

Thair Phillips is president of RetireSafe, a leading grassroots organization advocating on behalf of America’s seniors.

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