ICYMI: Big Pharma Continues to Profit From Patent Abuse

Humira Revenue Up 9.6% In U.S., But Down Abroad Due To Biosimilar

IN CASE YOU MISSED IT: The poster child for how big, brand-name drug companies abuse the patent system to keep drug prices high continues to reap the benefits from gaming the U.S. patent system. Yesterday, Inside Health Policy reported that Abbvie’s revenue from Humira fell by 33.5 percent internationally due to competition from biosimilar medicines. Comparatively, AbbVie’s revenue in the United States, where it is protected from generic competition by a patent thicket, increased by 9.6 percent. As the story notes, Abbvie has more than 100 different patents on Humira alone.

This report underscores what the Coalition Against Patent Abuse (CAPA) has been saying for some time: patent abuse that prevents competition allows Big Pharma to keep prescription drug prices high and stifle innovation and medical advancements.

Humira’s falling international revenues is yet another clear example of how reforming the patent system to allow for greater competition would serve as a crucial step in lowering prescription drug prices for American patients. The data is clear. If Humira’s patents had expired in 2016, then the drug’s price in the U.S. would be more affordable due to the availability of biosimilar medications.

Humira Revenue Up 9.6% In U.S., But Down Abroad Due To Biosimilars

Inside Health Policy, November 6, 2019

Humira revenues fell 33.5% internationally in the third quarter of this year due to biosimilar competition, according to AbbVie, while revenues increased 9.6% in the United States, where there is no biosimilar competition until 2023.

Humira tops the list of seven drugs with the biggest unsupported price increases, according to the Institute for Clinical and Economic Review.

Humira is one of the high-profile cases of patent settlements that delay generic or biosimilar competition, though AbbVie says the settlements are not so-called pay-for-delay deals because biosimilar makers will pay AbbVie royalties for non-exclusive licenses to market their drugs, instead of AbbVie paying biosimilars makers to delay market entry.

AbbVie’s initial patent for Humira expired in 2016, but follow-on patents have expiration dates stretching past 2030.

Senate Finance Committee Chair Chuck Grassley (R-IA) wrote a bill to ban pay-for-delay settlements, but it likely would not affect deals AbbVie has struck with makers of Humira biosimilars.

AbbVie has more that 100 patents on Humira. Sens. John Cornyn (R-TX) and Richard Blumenthal (D-CT) wrote a bill to limit the brand practices of “patent evergreening” and “patent thicketing,” but Minority Leader Chuck Schumer (D-NY) is blocking that bill, according to Cornyn.

At a February Finance hearing, AbbVie Chairman and CEO Richard Gonzalez said the drug has lots of patents because it treats several conditions.

The company is preparing successors to Humira for when the drug faces biosimilar competition, according to the Center for Biosimilars. FDA approved AbbVie’s oral small-molecule drug Rinvoq in August. The drug, which treats rheumatoid arthritis, launched at an annual list price of $59,000, just under the approximate $60,000 annual cost of Humira, the Center for Biosimilars says. The European Union is still reviewing the Rinvoq application.

Skyrisi, which FDA approved in April for the treatment of plaque psoriasis, also could help shore up lost sales due to Humira biosimilars, the Center for Biosimilars said. The drug is also being investigated in phase 3 trials for inflammatory bowel disease and psoriatic arthritis.