by Eric Sagonowsky | Aug 26, 2019
11:28am
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.
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