It’s no secret biosimilars haven’t made a big dent in U.S. drug spending. Some experts have even said it’s time to give up on copycat biologics. But former FDA commissioner Scott Gottlieb argues it’s too soon for that, and he's calling on Congress to bolster the budding market.
Instead of accepting defeat on biosimilars, lawmakers could tweak existing laws to promote them, Gottlieb wrote in a Monday op-ed in The Wall Street Journal.
For one, lawmakers could require branded drugmakers to sell samples to biosim developers at a fair price, Gottlieb argues. Biosim makers need hundreds or thousands of doses for testing, but branded companies “have an incentive to make it harder for biosimilar manufacturers to clear basic regulatory hurdles,” Gottlieb wrote.
That's on the development side. Congress could help approved biosims crack the market, too, Gottlieb says, by stifling rebate "abuses" that throttle competition. Of course, Gottlieb brings some industry experience to that argument: He's a director at Pfizer, which sued rival Johnson & Johnson over “anticompetitive” rebates that held back its Remicade biosimilar, Inflectra.
The Trump administration proposed an across-the-board rebate crackdown but pulled back after the Congressional Budget Office found it would boost federal spending by $177 billion over 10 years. Gottlieb called out brand-versus-biosim rebates specifically, though, saying, "If there’s one situation where rebates are anti-competitive, it’s when they’re being used to block competition from a low-cost generic."
Then there's the doctor-level barrier. The government could “invest more heavily” to teach doctors about biosim safety and efficacy, Gottlieb figures. When small-molecule generics launched in the 1980s, doctors worried they wouldn't match up to the brands, but that's changed: Low-cost generics accounted for 87% of dispensed drugs in 2015, he notes.
“The same initial trepidation is slowing adoption of biosimilars and costing patients billions,” the former FDA commissioner wrote.
Gottlieb’s op-ed comes after drug pricing expert Peter Bach and his colleagues wrote that biosimilars haven’t lived up to their initial promise and the U.S. would be better served by regulating prices after biologic drug exclusivities lapse. Instead of waiting for biosims to gain steam, the U.S. could save $50 billion per year by reimbursing branded drugs on a cost-plus basis, or by using another money-saving formula, the authors argued.
That's not a popular idea in pharma, and Gottlieb argued it would "discourage investment in manufacturing, as few drugmakers would want to produce complex drugs in perpetuity for little profit." And that, in turn, could trigger shortages, he figures.
As the experts all point out, biologic drugs are not easily copied and represent an outsized portion of drug spending. Congress introduced the biosimilar regulatory pathway along with the Affordable Care Act in 2010, but so far, the FDA has only approved about two dozen of the copycat meds. Thanks to patent litigation, far fewer have launched. Those that do reach the market face other obstacles, as Pfizer's Inflectra experience shows.
But there are signs that healthcare providers and payers are coming around. In a big win for the nascent field, Amgen’s biosimilars to Roche’s Herceptin and Avastin recently picked up coverage at UnitedHealth over the branded options. A group of oncology treatment centers also chose Amgen's copies over Roche's originals.