Safeguards
Needed for
Medications
Photos courtesy of Getty Images
FAMILY FEATURES
Thanks to a provision in the Patient Protection and Affordable
Care Act, efforts are underway to streamline licensing for medications known as “biosimilars,” which are similar – but not identical
– to cutting-edge biologic medicines. However, the development
has some concerned about patient safety, especially among older
Americans who tend to suffer from more chronic diseases, such
as cancer, diabetes, and heart disease.
According to the U.S. Food and Drug Administration (FDA), a
biosimilar is highly similar to a U.S.-licensed biological product (a
wide range of items including vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues and proteins) that may have minor differences in clinically inactive components, but (supposedly) no clinically meaningful differences in
terms of the safety, purity and potency. This is difficult to ensure
because both biologics and biosimilars are derived from complex
living organisms. Even different production facilities, shipping, or
storage could create meaningful differences.
Again, biosimilars are highly similar but not identical to their biologic originator and should not be confused with generics. Generic
medicines are traditional pharmaceutical medicines and have the
same exact active ingredient as their originator; therefore patients
can be switched easily from one to the other with the same outcome. However, it is possible that a biologic and a nearly identical
biosimilar could have different reactions for the same patient.
A few weeks ago the FDA accepted the first application for a
biosimilar, yet they have not released the safety standards, under
wh