The FDA just approved another new drug that could save the US billions — but there's a catch

The FDA just approved a version of Humira, the blockbuster arthritis drug made by AbbVie that brought in $14 billion in sales in 2015.

The drug, called Amjevita (adalimumab-atto), is a "biosimilar," which is like a generic version of a biologic medication, a medicine produced by living cells.

Biosimilars are a bit more complicated than your average competing medicine: Unlike generics for chemical-based drugs like antibiotics, which can be interchangeable with branded versions, the copycats of biologic medications have a few more caveats.

"This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions," FDA director Janet Woodcock said in a news release.

Having more biosimilars in the US would be a big deal: It might be the best way to drive down the cost of biologic medications that have been around for a while. The savings of putting people on far less costly biosimilars — even just new patients who have never taken the original — are estimated to be billions of dollars.

But, because of patent litigation, Amjevita might not be available for years.

"We anticipated Amgen's product would be approved," an AbbVie spokeswoman said in a statement. "AbbVie and Amgen are currently in litigation over AbbVie's Humira-related intellectual property."

It's the same thing that's happening with other biosimilars: A biosimilar version of Enbrel is currently also tied up in a legal dispute.

See more of the biosimilars:

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SAN FRANCISCO, CA - JANUARY 14: Michigan State University Psychiatry Professor Randy Hillard poses for a portrait outside the Asian Art Museum in San Francisco, Ca. on January 13, 2015. Hillard was diagnosed with stage 4 stomach cancer in 2010 and was told he had less than a year to live, but started receiving infusions of Herceptin. Hillard was a patient representative on the FDA panel that recommended approval of the first-ever U.S. biosimilar for Neupogen. (Photo by Nader Khouri for The Washington Post via Getty Images)
Employees of Biocon Ltd work inside the company's research and development centre in Bengaluru, India, October 16, 2015. India, which has dominated the generic drugs industry for decades, is falling behind in the race to make copies of complex biotech drugs, which are expected to generate tens of billions of dollars in sales in the coming years. REUTERS/Abhishek N. Chinnappa
An employee of Biocon Ltd works inside the company's research and development centre in Bengaluru, India, October 16, 2015. India, which has dominated the generic drugs industry for decades, is falling behind in the race to make copies of complex biotech drugs, which are expected to generate tens of billions of dollars in sales in the coming years. REUTERS/Abhishek N. Chinnappa
UNITED STATES - FEBRUARY 12: Ganesh Venkataraman, chief science officer of Momenta Pharmaceuticals Inc., stands for a photo in a lab at Momenta Pharmaceuticals headquarters in Cambridge, Massachusetts, U.S., on Thursday, Feb. 12, 2009. Momenta Pharmaceuticals Inc. may become the first drugmaker to win U.S. clearance to sell generic versions of a biologic medicine, giving the unprofitable 8-year-old company a head start on President Barack Obama's plan to trim health-care costs by making such copycats commonplace. (Photo by Michael Fein/Bloomberg via Getty Images)
UNITED STATES - FEBRUARY 12: Liquid is poured from a beaker in a lab at Momenta Pharmaceuticals headquarters in Cambridge, Massachusetts, U.S., on Thursday, Feb. 12, 2009. Momenta Pharmaceuticals Inc. may become the first drugmaker to win U.S. clearance to sell generic versions of a biologic medicine, giving the unprofitable 8-year-old company a head start on President Barack Obama's plan to trim health-care costs by making such copycats commonplace. (Photo by Michael Fein/Bloomberg via Getty Images)
UNITED STATES - FEBRUARY 12: He Wang works in a lab at Momenta Pharmaceuticals headquarters in Cambridge, Massachusetts, U.S., on Thursday, Feb. 12, 2009. Momenta Pharmaceuticals Inc. may become the first drugmaker to win U.S. clearance to sell generic versions of a biologic medicine, giving the unprofitable 8-year-old company a head start on President Barack Obama's plan to trim health-care costs by making such copycats commonplace. (Photo by Michael Fein/Bloomberg via Getty Images)
FDA just approved its second biosimilar. More important still: Education still needed. https://t.co/yEvTlq7jri https://t.co/TgY0702zcl
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What makes biosimilars different from generics

Developing a biosimilar is not as easy as creating a generic knockoff; because you're working with complex living things, making a copy isn't so simple.

"When you have a small molecule like Lipitor, you know where every single atom is," Dennis Lanfear, CEO of biosimilar company Coherus Biosciences, told Business Insider in April.

That's not the case with something like a monoclonal antibody — a type of lab-produced protein that can go after certain cells like your immune system would — which can vary widely. This means that you have to run the biosimilar through a bunch of studies to prove that it does the same thing that the original drug does, making development not only more complicated but much more expensive.

Coherus is developing biosimilar versions to drugs for autoimmune diseases and cancer treatment, including biosimilar versions of both Humira and Enbrel. It plans to file a biologic-license application to the FDA for its version of pegfilgrastim, a bone marrow stimulant, in 2016.

"Biosimilars are here," Lanfear said.

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