The FDA says that biosimilars are just as safe and effective as their reference products, but that fact—among many others that shed a positive light on these pharmaceuticals—is often lost in a blizzard of misinformation, argue two spokespeople for the industry. The makers of costly reference biologics try to mislead public opinion, argue Hillel P. Cohen and Dorothy McCabe in Stat. Cohen and McCabe, co-chairs of the Biosimilars Forum Education Committee, say that there are many examples of pharma companies spreading misinformation.
For instance, yes, the FDA does require that biosimilars be highly similar to the reference biologic but the public doesn’t often hear “that approved biosimilars have no clinically meaningful differences from the reference product.” Cohen and McCabe also argue that “batch-to-batch variability for biosimilars is permissible—and is routine for reference products.”
They point to how biosimilars have fared in Europe since their introduction in 2006. They write that “there have been more than 700 million patient days of exposure to biosimilars and no new safety concerns have emerged that were not previously observed with the reference product, according to the European Medicines Agency.”
They want to see a ban on fail-first policies, in which a biosimilar cannot be prescribed until the originator biologic has first been tried. Patients who do not respond to a reference product will also not respond to the corresponding biosimilar, they argue.
“Patients should not be forced into taking a more expensive biologic and should instead be given the opportunity to take the cheaper biosimilar version from the start of their treatment. That way, even if a patient does fail on the biosimilar, he or she did not have to pay as hefty of a price tag by taking the originator biologic.”