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Calling it quits on biosims outside the U.S., Boehringer bets big on Humira patent fight

Boehringer Ingelheim is hoping for big things from its Humira biosimilar in the U.S.—so much so that it’s giving up on copycat biologics in other countries.

That move, reported by BioProcess International, comes despite the fact that Boehringer can’t yet launch its Humira copy in the U.S., thanks to AbbVie’s staunch defense of its myriad patents on the brand.

Boehringer is apparently betting big on a court fight over those very patents. Indeed, it’s among the last late-stage biosimilar makers still scrapping with AbbVie in court, eyeing a lucrative chance to roll its own FDA-approved Humira copy, Cyltezo, years before AbbVie’s 2023 target date. The rest of the would-be Humira copycats have agreed to hold off on their own launches till then, and several have launched in Europe in the meantime under settlements with AbbVie.

That heavy load of competitors in Europe—four biosim makers are now jostling for share with AbbVie’s own brand—plus AbbVie’s own willingness to offer major discounts, may have played into Boehringer’s decision to abandon the market.

A BI spokeswoman told FiercePharma the company's “focus is on bringing Cyltezo to the U.S. market, and we are committed to making it available to U.S. patients as soon as possible and certainly before 2023.” Boehringer won’t launch Cyltezo in Europe because of the patent fight with AbbVie, she said.

Humira is the best-selling drug in the world, generating more than $18 billion last year, and AbbVie has aggressively pursued legal claims against would-be copycats, including Boehringer. In defending against AbbVie’s suit, Boehringer argues that the Illinois drugmaker acted inequitably by pursuing overlapping and non-inventive patents, creating a “patent thicket” around Humira.

As of AbbVie’s third-quarter conference call, the drugmaker had inked five patent settlements protecting Humira, which CEO Richard Gonzalez said highlight the “strength of our intellectual property.” The drugmaker added another settlement with Momenta a few days later. Gonzalez said AbbVie is “confident that we will not see direct biosimilar competition in the U.S. until 2023."

That’s a big deal for AbbVie as it battles Humira knockoffs in Europe by striking discount deals that’ll cut into its regional sales. In one country that buys drugs via a tender process, AbbVie reportedly offered up an 80% discount on Humira to keep the business.

Gonzalez admitted on the call that discounting “has been on the higher end of the planning scenarios that we had laid out.” It has fought back against biosims by cutting prices by 10% to 80%, he said.

Though Humira is a megablockbuster outside the U.S., too, it’s a much bigger moneymaker in the States. The drug generated $12.36 billion in the U.S., compared with $6 billion in all other markets last year.

Editor's note: This story was corrected to note that Boehringer Ingelheim is not the only late-state biosim maker still fighting over Humira patents.

Nov 29, 2018


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