It's no secret that biosimilars have failed to make a big splash in the U.S. market since the first one launched stateside in 2016. And that's despite some hot anticipation up front, not only from payers intent on saving money on pricey biologic meds but from Big Pharma companies looking to capture their piece of the biosims sales pie.
What's the holdup? Researchers at Trinity Partners did some digging, and they've turned up three major obstacles to boosting biosim uptake in the U.S. Pricing agreements are complex, doctors and patients remain dubious of the new alternatives and makers of the original branded meds have put up a tough fight, both in court and in the promotional sphere, according to the report (PDF), which is based on conversations with medical directors at 10 top U.S. payers.
Drug pricing is opaque, the report notes, and behind-the-scenes negotiations keep payers in the dark about pricing for their counterparts. Rebates and exclusive contracting have conspired to stymie new biosims in their efforts to steal share from entrenched biologic brands, as well.
Even beyond the payer-negotiations sphere, those entrenched companies have gone to great lengths to protect their cash cows—and they're unlikely to change that stance, the report notes. Many drugmakers have sued their would-be biosimilar rivals for patent infringement while those meds are still in development, setting up a legal barrier to any launch.
Meanwhile, branded drug companies are shelling out hundreds of millions to build patient loyalty as biosims work their way through the development process. AbbVie, for one, spent $341 million last year to promote the world's bestselling drug, Humira, in TV ads, according to real-time TV tracker iSpot.tv.
AbbVie has also inked a patent settlement with Amgen that will delay the latter company's Humira biosimilar market launch until 2023, despite the fact that the biosim won FDA approval in 2016.
Biosims are also having trouble getting over basic doubts by doctors and patients, the report notes. Many approved biosims treat chronic conditions, and many docs and patients are hesitant to switch—even to a drug proven equivalent in clinical trials—if their current drugs are working.
How are payers reacting? One medical director quoted in the report cited a "general disappointment in the whole system" after early biosims launched with only small discounts to the brands. Pfizer's Inflectra, for instance, launched at a 15% discount to Johnson & Johnson's Remicade and hasn't captured meaningful market share. Pfizer has discounted Inflectra further since its launch.
Importantly, the New York drugmaker also sued J&J for "anticompetitive" contracting it says is blocking biosimilar uptake. Pfizer says J&J tied discounts on the existing Remicade patient base to the stipulation that payers don't adopt biosims, effectively shutting out the competition. J&J responded that Pfizer isn't offering enough value to win business.
Despite the disappointment cited in the report, at least one of the payer execs says biosims have a "bright future if additional work is done to be attractive to prescribers and payers."
"I still expect they will get 50% [market share], but only if there is steep discounting, or interchangeability status," the medical director of a large national payer told Trinity researchers.
In all, the Trinity team concluded that payers are reacting to biosims with four general approaches: protecting the status quo, waiting to see how the market plays out, passively pushing patients to biosimilars and actively promoting them with formulary tiering and restrictions. Right now, most are either biding their time or passively pushing patients toward the copies, the report states. Not surprisingly, payers are expected to take more aggressive action as the years go by and more biosims make their debuts—and they themselves seek to save more money.
One key pivot point is the physicians' office, Trinity principal Jillian Godfrey Scaife said in an interview. As doctors become more comfortable with biosims, payers are more likely to pressure members to use them.
"Most of the plans we spoke to ... were waiting and seeing or passively pushing for the adoption of biosimilars," she said. "I do think that with increasing clinical comfort, we could see some payers switching" to a more aggressive stance.