What do physicians think about biosimilars?
How has the messaging and education about biosimilars been received by doctors? To find out, MM&M asked Sermo, a leading social network for physicians, to poll its members on the following question: “Several biosimilars (products that are bioequivalent to biologics) are currently approved for the U.S. and European markets and many more will follow in the near future. In general, do you feel biosimilars will prove safe and effective enough for you to prescribe them when more become available?”
Of the 3,478 physicians who responded, 1,631 said yes, 342 said no, and 1,505 said they “would need more educational information on biosimilars.” Of the 1,789 respondents from the U.S., 786 said yes, 148 said no, and 855 said they “would need more educational information on biosimilars.”
Here are a few comments that respondents shared:
U.S. ophthalmologist: “Given the huge discrepancy between branded drugs and generics that we see in simple eyedrop formulations, I hate to think how different the biosimilars could be. I don't really have any knowledge of this, though.”
U.S. rheumatologist: “Are they ‘safe' and are they ‘effective'? Who knows? In order to save a buck, these — new compounds — are being approved for marketing for numerous diagnoses for which no studies have been performed. Sort of like ‘deeming' that a bill before Congress passed. Sorry. Each biosimilar is a 100% completely new compound. Approving such a totally new chemical compound to be marketed to treat potentially millions of patients with a half dozen different diagnoses ... without thorough testing? Is political idiocy ... Not medical science. Nobody knows if they will be ‘safe.' Nobody knows if they will be ‘effective.' Certainly not the FDA or any of the European drug-regulatory agencies. Not for my child, thank you. Not for my patients. The FDA is proposing taking very promising compounds and turning them into treatments one step away from snake oil (which was also marketed without appropriate testing).”
U.S. gastroenterologist: “Biosimilar agents are still untested, so safety and efficacy cannot be known without clinical trials. Non-inferiority and safety trials should be carried out versus the biological equivalent. After testing, they might be proved safe and effective. But that would require huge amounts of funds and a minimum of 10 years of studies. Unfortunately, since this initial testing has been skipped, biosimilars will probably have a negative effect on patient outcomes if only by lack of physician trust on the drug or lessened patient compliance (when the debate becomes more public). Another issue that could arise is the availability of different drugs within a category. So you might get biosimilar enoxoparine, but no deltaparine or nandroparine, or rosuvastatin but no atorvastatin or simvastatin, thus limiting patient-tailored care. I have faith that in 10 to 20 years biosimilars will probably be safe and effective, as no industry thrives long by losing ‘clients,' but right now things are looking like they will get worse before they can get better.”