When AbbVie’s record-breaking immunotherapy drug Humira went off patent early last year after generating more than $200 billion in sales for the company over two decades, a slew of cheap imitations known as biosimilars hit the market. Ta. But AbbVie’s monopoly remained largely intact.
U.S. sales from the world’s best-selling drug, which is used to treat inflammatory conditions from arthritis to Crohn’s disease, are backed by AbbVie’s lucrative rebates to industry intermediaries called pharmacy benefit managers (PBMs) to maintain prescription volumes. As a result, the number of sales decreased by one third. But AbbVie’s incoming chief executive officer, Robert Michael, concluded at an investor event earlier this year that the arrival of generic drug competition is “doing very well.”
That was until this month, when CVS Caremark, one of the three major PBMs, removed Humira from its list of preferred drugs for reimbursement. Biosimilars accounted for 2% of all Humira prescriptions at the end of March, but jumped to 19% in mid-April, according to data provider IQVIA.
This is due to a surge in prescriptions for Sandoz’s Hirimoz, a CVS-recommended biosimilar, which was administered to more than 10,000 patients in the week ending April 12, and biosimilars accounted for new prescriptions for Humira. The proportion has been pushed up to 43%.
What happens next will depend on whether generic drug competition can serve its purpose of lowering skyrocketing drug prices in the U.S. or the disproportionate influence of the three largest PBMs, who are in powerful positions with politicians and regulators. This is expected to be the biggest test to date, testing whether the impact of Curb market forces.
The results could have ripples beyond the industry. U.S. President Joe Biden has made fighting Big Pharma a centerpiece of his re-election campaign, championing efforts to lower drug prices through the Anti-Inflation Act.
“Is the biosimilar market a failure when it comes to medicines that are beneficial to pharmacies like Humira? Maybe it was in March, but it’s starting to work again in April,” says healthcare consultancy Matrix Global.・Alex Brill, Chief Executive Officer of Advisors, said:
A report released this month found that of the nine approved Humira biosimilars, delays in PBM promotion and reluctance by pharmacists to prescribe them are driving down biosimilar prices. The drug’s level was one-fifth that of the original drug, resulting in a loss of $6 billion to patients and health insurance plans. By the Biosimilars Council, an industry group. They estimate that PBMs would lose 84% of the $2.1 billion in net profits they earned from Humira if biosimilars became fully available.
In a statement, Sund called AbbVie’s continued dominance “the epitome of a dysfunctional market.” “Misaligned incentives across the U.S. healthcare system have significantly delayed and created barriers to biosimilar adoption, resulting in significant missed opportunities for healthcare cost savings.”Swiss Generics the manufacturer stated.
Two other large PBMs, UnitedHealth Group’s OptumRx and Cigna’s Express Scripts, continue to prioritize Humira on their formulation lists because AbbVie offered larger rebates. Insurer-owned benefit managers argue that these rebates are passed on to patients in the form of lower premiums, but that they are pocketing some of the discounts for themselves.
OptumRx told the Financial Times that it offers three biosimilars that are “comparable” to Humira, and that “by adding both high- and low-price options, customers can choose the best option for plan design and membership.” We’ll give you a choice,” he said.
Whether other major PBMs adopt biosimilars will determine how quickly Humira’s competition expands. In addition to signing a co-branding agreement with CVS to offer Hirimoz at a discounted price of $1,315 per month, Sandoz also has a biosimilar version of Humira with a list price of more than $6,000 per month. A large rebate on top of that to attract OptumRx and Express Script to promote the drug.
“We hope that in 2025 the market will open up further and other products will replace Humira,” Sandoz said.
AbbVie said in its financial guidance that an invasion of Humira by a rival company was “anticipated and considered.”
PBMs are facing increasing pressure from the Federal Trade Commission, U.S. antitrust regulators, and bipartisan legislation aimed at increasing the adoption of biosimilars.
“[PBMs] Douglas Holtz Eakin, president of the right-wing think tank American Action Forum, said: But these groups “want to solve their problems themselves, not rely on politicians to solve them for them,” he said.
Despite Sandoz’s incursion into Humira’s territory, generic drug makers remain cautiously optimistic. “It’s too early to put up a ‘Mission Accomplished’ sign,” said Craig Burton, executive director of the Biosimilars Council. “Big PBMs are making money every step of the way by sticking to their brand, and it will take a lot of time to shake them out of that mindset.”
“CVS is [biosimilar] Manufacturers are being rewarded,” said John Martin, head of U.S. biosimilars at Organon, which produces Humira’s competitor Hadrima. “I think other PBMs will gradually reach that position, because if you want competitive market dynamics, you have to start rewarding biosimilars.”
Two Humira biosimilars, Organon Inc. in partnership with Samsung Bioepis and Teva Pharmaceuticals Inc. in partnership with Albotech, were first approved for compatibility by the U.S. Food and Drug Administration earlier this year, allowing pharmacists to It can now be used as a replacement for Humira without consulting the company.
Martin predicted that competition will increase next year when interchangeable biosimilars are added to major PBM formularies.
“Every PBM will want to offer every biosimilar available. Creating real competition will drive the market,” said US billionaire Mark Cuban. The company’s drug discount company, Cost Plus Drugs, has a deal with manufacturer Coherus to sell the biosimilar for $995 a month.
The Cuban government is targeting the 38% of private sector employers who self-insure at least one health insurance plan. “The real tipping point will be when employers require self-insurance. . . . Other biosimilars will also be included in the formulary,” he added.
Nevertheless, Deutsche Bank biopharma analyst James Shinn said the sharp increase in biosimilar prescriptions in recent weeks could be “alarming” for AbbVie. “I think many people are expecting to see some significant erosion in AbbVie’s U.S. Humira business this year,” he said.
