Amgen's Humira biosim, Amjevita, passes FDA milestone on long road to market

FDA sign

Amgen’s Humira biosimilar is now officially FDA-approved. It has an official brand name, Amjevita. But that doesn’t mean it will come to a pharmacy near you anytime soon.

That’s for two reasons: For one, a required 180-day notice period means that at best, the California company could launch its Humira copy next March.

For two, because AbbVie, which makes the $14 billion Humira original, has sued for patent infringement, claiming that Amgen’s biosim steps on 10 AbbVie patents. And as usual with these sorts of lawsuits, AbbVie also asked the court to block Amgen’s drug if and when the FDA issued an approval.

It was all but a foregone conclusion that the agency would do just that when Amjevita won the unanimous backing of an FDA panel in June. By a 26-0 vote, the committee voted to recommend Amgen’s biosim for 7 Humira indications, with some members citing a "robust" data set that made the vote “easy.”

Still, the biosimilar approval process is a nascent one, as Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, pointed out in the FDA’s approval announcement. Amjevita is the fourth biosimilar to win the agency’s blessing. “The biosimilar pathway is still a new frontier,” Woodcock said.

Every drug to follow that pathway offers clues to those biosims hoping to follow, and at this point, every biosimilar patent case--the so-called patent dance governed by the legislation that created that biosimilar pathway--does the same. The Humira patent case presents a delay long past March, depending on the court’s decision on an injunction and AbbVie’s all-but-certain appeal. With $14 billion in sales at stake, AbbVie has been working to shore up its Humira IP, and the company has repeatedly said it believes it can hold off biosimilars until 2022.

"Humira is protected by many patents covering all aspects of its manufacture, formulation and indications and the patents are the result of AbbVie’s investment in biologic innovation and the unique attributes of Humira,” company spokesman Greg Miley told FiercePharma earlier this year.

To that end, AbbVie is not only suing Amgen to defend those 10 Humira patents, but also threatening to follow up with more court challenges. In its complaint, AbbVie claims that Amgen’s product infringes 51 more patents as well. Amgen’s “blatant infringement” should be stopped, AbbVie says.

It’s true that, if Amgen felt confident enough of its standing, it might roll out Amjevita with an “at-risk” launch, which would put it on the hook for damages if AbbVie ended up prevailing. But analysts aren’t convinced Amgen would take that step. Amgen appears unwilling to wage an at-risk launch “at least in the near term,” Evercore ISI analyst Mark Schoenbaum wrote in a note as the FDA panel vote approached.

Of course, the U.S. biosimilars legislation was designed to allow for patent litigation, and Amgen itself has benefited from those provisions. The California biotech stalled the first FDA-approved biosim--Zarxio, a Novartis ($NVS) copy of its Neupogen drug--for 6 months after its approval last spring.

In fact, the AbbVie lawsuit aims to capitalize on Amgen’s own biosimilar defense. In delaying Zarxio, Amgen claimed that biosimilars “[piggyback] on the fruits” of “innovators’ trailblazing efforts." That shows that Amgen is “speaking out of both sides of its mouth” on biosimilars. “While Amgen may hope to profit by straddling the fence, it should be held to the positions it has taken in procuring its own patents and litigating those patents against biosimilars,” the lawsuit claims.

Amgen isn’t the only company looking to grab a piece of the Humira pie. Novartis; Merck and its partner Samsung Bioepis; and partners Baxalta and Momenta Pharmaceuticals all have their own Humira biosims in development.

Meanwhile, Amgen is working with Allergan ($AGN) on biosimilars of Eli Lilly's ($LLY) Erbitux and Roche's ($RHHBY) Avastin, Herceptin and Rituxan. On its own, the company is also developing a version of Merck’s Remicade.

Special Report: The top 20 drugs in 2020 by worldwide sales - Humira

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