Future in doubt for near-copies of complex, expensive drugs BIOSIMILARS

FDA attempts to enable faster approval


AP Medical Writer


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 such as 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, says 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.

A decade ago, Congress passed a law meant to encourage development of cheaper biosimilars. But the makers of the original biologic drugs have fought hard to block the new rivals, with stacks of successive patents, lawsuits and rebates to insurers.

The result? Even drugmakers with the expertise and resources to produce biosimilars are mostly thwarted.

In the U.S., that is.

In Europe, monopoly-protecting patents generally don’t last as long as in the U.S. and government-run health systems have favored biosimilars in exchange for steep discounts.

Biosimilars hit Europe in 2006. Now 54 are available at discounts up to 80 percent.

In the U.S., the FDA has approved 24 biosimilars, nearly all since 2015. Just 11 of them are actually for sale, generally at 15 to 35 percent below the original drug’s price. Those discounts are easily matched by original biologic makers who prefer insurers give them a smaller piece of the pie than nothing.

Biosimilars have been approved in the U.S. for five biologic best-sellers on the market as long as 22 years: Humira and Enbrel, for rheumatoid arthritis, psoriasis and other autoimmune disorders, and the cancer drugs Herceptin, Rituxan and Avastin. However, their biosimilars can’t be sold in the U.S. due to litigation and multiple, monopoly-extending patents.

The brands have monthly list prices of over $5,000 to nearly $13,000. Health plans pay much less, but even well-insured patients must pay a big portion – or the full price until they cover their plan deductible.


Drugmakers have been harnessing scientific advances to create targeted biologic drugs, many for cancer and rare conditions without good treatments. Their executives predicted insurers wouldn’t balk at high prices because the patient numbers aren’t big.

But as more people took biologic drugs and companies increased prices up to 20 percent every year, insurers and middlemen called prescription benefit managers limited patients’ access. They also set high co-payments for many patients.

Biosimilars were seen as financial salvation. But given their limited sales to date, the FDA is trying to enable faster approval.

In May, it issued guidelines to enable biosimilar-makers to show their products are interchangeable with an original biologic drug. Pharmacies then could substitute a biosimilar for a brand-name biologic, as happens routinely with generic pills.

Cancer patient David Mitchell, who founded the advocacy group Patients for Affordable Drugs, says biologic drugmakers are exploiting the system, despite having at least 12 years of market exclusivity.

“We have patients who say, ‘I’ve been taking this drug for 15 or 20 years and there’s still no generic,’” Mitchell notes.

He says the group also hears frequently from patients on biologic drugs “who are struggling or can’t afford them.”

Last year, the U.S. spent $126 billion on biologic drugs, only 2 percent of it on biosimilars, according to the health data firm IQVIA.

Gottlieb, the recently departed FDA commissioner, blames the slow uptake partly on doctors hesitant to switch patients to unfamiliar alternatives. He also points to barriers erected by the companies behind name-brand biologic drugs.

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