How costs will be affected
Ultimately, insurers and health systems will likely “drive the uptake” of biosimilars by restricting use of biologics via negotiated pricing, Lyman says. Biosimilars will likely enter the market priced at a 20 to 40% discount to their reference competitors, predicts Forys.
“I anticipate that the uptake of biosimilars in the U.S. will be more gradual than in Europe,” Lyman says of oncolytic biosimilars. “The U.S. healthcare system is far more independent, with the majority of cancer patients treated in the community.”
Some clinicians will be uneasy with newly-approved biosimilars compared to the original reference biologics.
And, as anticancer biosimilars launch, patients and oncologists are going to be “very, very concerned” about substituting branded oncolytics, considering the life-and-death stakes, says Ambrose Carrejo, PharmD, national pharmaceutical contracting leader at Kaiser Permanente.
Many branded biologics have strong patient copay assistance programs in place, he says.
Lyman agrees. “There will likely be concern about switching from previously approved biologics of known safety and efficacy to new biosimilars approved with much less clinical data supporting efficacy and safety along with extrapolation of approval to other indications with little or no data provided,” he says. There will be concerns about possible rare or delayed toxicities, so postmarketing surveillance will be “critical” for clinical acceptance.
“We need to be able to identify and track different forms of biologics [and] biosimilars in practice and identify unusual or delayed toxicity or loss of efficacy,” he says. “It is also critical that providers be notified when a patient is switched from a reference product to a biosimilar, or between biosimilars.”
If biosimilars do become well-accepted, the savings could be profound. A recent analysis by the Rand Corporation suggests that biosimilars could cut healthcare spending in the United States by more than $50 billion over the coming decade.
Not everybody is as optimistic, however.
“How will biosimilars affect costs overall? They may not, is my concern,” Carrejo says.
He points to the recent Remicade (infliximab, J&J) biosimilar Inflectra (infliximab-dyyb, Pfizer) as one sign of potential trouble ahead.
Inflectra has been trying to capture market share from infliximab and Pfizer has filed suit against J&J in federal court over allegedly suppressing price competition from biosimilars using exclusionary contracts.
Pfizer launched Inflectra in 2016 at a 15% discount compared to Remicade’s price. But a year later, Inflectra had captured only 2.3% of infliximab volume, according to a 2nd quarter investors’ call.
If that’s the market share biosimilars manufacturers can look forward to, Carrejo says, “one can imagine that they are going to take their football and go home—that, you know, there’s just no money in biosimilars,” he says. “That would be catastrophic. How else are we to create competition in this branded arena and prevent or mitigate some of the pricing actions that have been going on year over year over year in the form of multiple price increases, double-digit, with no added innovation or added value in that product? In my mind, that would just be a shame if the robust biosimilars market that we dreamt of, came and went before prices were affected.”