The TNF-α blocker may be the world’s top-selling drug, by revenue. It faces biosimilar competition in Europe. Nonetheless, it will be four years before it’s challenged in the U.S.
Many people living with rheumatoid arthritis are receiving rest from their pain with Humira, but it’s prone to take until 2023 until they get any rest from the hefty price for his or her medication.
Competition is waiting in the wings, although it stands to be quite a delay before Humira has biosimilars nipping at its heels. The FDA has approved three Humira biosimilars: Sandoz’s biosimilar Hyrimoz (adalimumab-adaz), Boehringer Ingelheim’s Cyltezo (adalimumab-album), and Amgen’s Amjevita (adalimumab-atto). But due to patent disputes, none of them are expected to be on the market until 2023.
Obviously, the Humira biosimilars are one of many in facing a tortuous obstacle length of patent and other challenges even after they have the FDA’s stamp of approval. The FDA has approved 16 biosimilars. Only six are now actually for sale.
“Brand-name biologics [manufacturers] have abused the patent process” to keep competitors away, says Greg Gierer, senior vice president for at AHIP.
It is a different situation in Europe. Humira’s patent expired there in October. Competitors immediately rushed in and launched biosimilars—in a few countries, with steeply discounted prices.
Humira treats rheumatoid arthritis and other inflammatory conditions, such as psoriasis and Crohn’s disease, by blocking a defense mechanism protein called tumor necrosis factor-alpha (TNF-α). Some people produce too much TNF-α, causing inflammation. By binding to the TNF-α molecules and blocking them from attacking healthy cells, it helps to lessen the damage brought on by an overproduction of TNF-&alpha.
The FDA approved Humira in 2002, and it was on the market the following year. Patients typically self-administer a 40-milligram injection every other week.
The FDA has approved other TNF-α inhibitors, including Remicade (infliximab), Enbrel (etanercept), Simponi (golimumab), and Cimzia (certolizumab).
The usage of TNF-α inhibitors and biologics, more generally, to treat RA has been groundbreaking. “You rarely see anyone seriously disfigured. Biologics have transformed lives for so many people,” says Sheila Frame, vice president and head of biopharmaceuticals for North America for Sandoz. Humira cost has shown staying power. One long-term study of patients on the drug found that most patients have been on adalimumab for 12 months, five years, and eight years were in remission or classified as having “low disease activity”—a standard measure for gauging RA.
But as with so lots of the biologics, Humira’s clinical benefits have been overshadowed lately by alarm—and arguments—about its price. Citing information from SSR Health, a health information company, the New York Times reported early last year that the price tag on Humira has doubled, from about $19,000 per patient each year after rebates in 2012 to a lot more than $38,000. The Wall Street Journal reported earlier this month that AbbVie had raised the price tag on the drug by 6.2% at the beginning of this year. U.S. drugmakers say list prices could be misleading and that much of the amount of money gets siphoned as rebates to intermediaries.
When Humira’s patent expired in October in Europe, Novartis, Mylan, Biogen, and Amgen immediately began selling their biosimilar versions of the drug. Soon afterward, AbbVie lowered its projections for 2019 overseas sales by 26% to 27%. In a meeting call with analysts, CEO Richard Gonzalez said the company had seen discounting of between 10% and 80%, with the maximum discount in Scandinavian countries, according to media reports. “The discounting has been on the higher end of the planning scenarios that people had laid out.”
While Gonzalez predicted discounting would moderate, later on, Geoffrey Porges, an analyst with Leerink Partners, a Boston investment bank devoted to the health care sector, told Reuters, “We would expect erosion to intensify in 2020, not slow.” That could be a dark cloud coming for AbbVie and its Humira-infused revenues, but it’s good news for payers and patients.
Meanwhile, their state of California has sued AbbVie, alleging it gave illegal kickbacks, including cash, meals, and gifts, to providers to prescribe Humira. The business has denied the allegations.
Kent Kwasind Huston, MD, an American College of Rheumatology board member who is on staff at St. Luke’s Hospital in Kansas City, says the cost would be the main factor that may induce physicians to change patients to biosimilars.
“Hopefully, as more biosimilars enter the marketplace and physician experience in using these drugs grows, the entire cost of biologic medications will decrease,” says Huston. “To date, the introduction of biosimilars in rheumatology has been a slow process. The fee savings have been underwhelming to date, but there is hope that this can change as more biosimilars become obtainable in the future.”