Pfizer gets biosimilar approved for Humira, setting up competition — in 2023
In the story lawmakers and drug pricing reform advocates have told about the drug industry, there are perhaps few greater villains than Humira and its maker AbbVie.
Between 2012 and 2018, AbbVie upped the drug’s annual after-rebates cost from $19,000 to $38,000 in the US, with sticker prices now over $60,000 per year — increases that led to accusations of price gouging, most recently from Democratic presidential frontrunner Elizabeth Warren.
“Humira is used by millions of patients around the world to treat diseases like arthritis, psoriasis, and Crohn’s disease,” Warren tweeted Saturday as part of a thread on drug prices. “But its manufacturer, AbbVie, doubled its price—and used blatantly anti-competitive behavior to prevent a competitor from entering the market.”
But massive drug pricing bill or not, that reality will change in 2023 when several biosimilars are set to come to market. Another one just officially joined the list as Pfizer earned the FDA nod for its biosimilar, ABRILADA.
Along with several other companies, Pfizer was sued by AbbVie as the old American pharma developed their rival drug — a not uncommon move in the biosimilar world. Pfizer settled last year. Like Amgen, Mylan, Samsung Bioepis, Sandoz, Fresenius Kabi, and Momenta all did, they agreed to roll out their biosimilar in 2023.
At the time Boehringer Ingelheim was the last holdout, telling The Center for Biosimilars “we are committed to making it available to US patients as soon as possible, and certainly before 2023.” They signed an agreement in May to release their drug, Cyltezo, in 2023.
Pfizer billed the news as an opportunity to help patients in the long list of indications that have made Humira a blockbuster: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. The FDA touted the move as the 25th ever biosimilar approval and the 9th this year.
The wide indication has led to huge revenues for Abbvie — $3.89 billion in Q3 2019 alone — and improved quality of life for many patients, but the high prices have led to stories of patients staggering doses to manage the cost.
“During the holidays, I was contemplating what am I’m going to do,” one 51-year-old woman with colitis and Chron’s disease told The New York Times last year. “I was thinking should I just go on a liquid diet, because I can’t afford this.”
Competition should send the prices down when the biosimilars rollout. Eight are to be released that year under settlements with AbbVie, beginning with Amgen’s Amjevita on January 31st. Not all have been FDA approved yet.
Pfizer will be the last to join the party, with their rollout date scheduled for November 20, 2023. They have yet to gain EMA approval but can market the drug in Europe the moment they pass that hurdle.
AbbVie, though, is not yet out of the woods. Shortly after Boehringer settled the last of the intellectual property rights cases, a class action suit was lodged alleging AbbVie used its “patent thicket” to create an illegal monopoly and that AbbVie colluded with the biosimilar competitors to divide the market.
