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TRENTON, N.J. -- They were the drugs that were supposed to save the U.S. tens of billions of dollars.
Called "biosimilars," they are near-copies of complex and expensive biologic drugs to treat cancer, rare diseases and autoimmune disorders like rheumatoid arthritis and colitis.
But U.S. sales have been so limited that their future is in doubt. Already, one company has scrapped nearly all its biosimilar development projects.
Worst-case scenario? Drugmakers could abandon biosimilar development, and makers of original biologic drugs could keep raising their six-figure-a-year prices indefinitely.
Two years ago, the independent policy research group RAND Health predicted biosimilars would save the U.S. roughly $54 billion from 2017 through 2026. That's looking optimistic.
"This is a make-or-break period," said Dr. Scott Gottlieb, who led the Food and Drug Administration until April. "My fear is that some of the biosimilar-makers … will say, 'We'll just go back to doing other things,'" and other drugmakers won't enter the niche.
Leigh Purvis, AARP's director of health services research, said the original biologic drugmakers "could kill this market before it ever takes off, and we desperately need it."
Biosimilars are akin to generic drugs, but true generics aren't possible with biologic drugs.
Pills are easily duplicated by mixing chemicals. Getting a generic version of a brand-name pill approved requires spending about $2 million and two years to conduct lab tests and show it's chemically equivalent to the original medication. Manufacturing costs just pennies a pill.
Biologic drugs, on the other hand, are made by manipulating living cells to produce a specific protein. They treat disorders often caused by faulty genes or immune systems, and they must be injected or delivered by infusion.
The complex process needed to grow and purify the proteins means a copycat biosimilar will never be identical to the original drug. But it also can't have "clinically meaningful" differences. Getting approval can take five to nine years of lab and patient testing, and cost over $100 million.