Here Come the Humira Biosimilars

The first Humira biosimilar is finally available in the US: Amgen’s Amjevita. It’s been over two decades since the FDA approved AbbVie’s Humira, but biosimilars are finally set to enter the US market. Another ten biosimilars on top of Amjevita are expected in 2023…

So I was interested to come across this (free to download) white paper on Humira from Goodroot, which expects Humira biosimilars to have a tough start in the market. For one thing, Humira rebates could make it difficult for biosimilars to get onto formularies for 2023; in fact, the report goes as far as saying that Humira’s preferred placement on formularies has historically been “untouchable.” The report also adds, “AbbVie will likely increase their rebate above their current range for Humira’s net cost after discount to remain competitive in the marketplace and retain preferred status on most PBM formularies. They will also likely increase rebates for Skyrizi and Rinvoq to maintain a preferred position for all three products on formularies.”

Amgen seems to be aware of the challenges that lay ahead and has launched its biosimilar with two different list prices: one that is 5 percent lower than Humira, and another version that will be available to some patients with a discount of 55 percent.

Cost savings caused by the entry of Humira biosimilars are expected to be “minimal” initially, but could capture a market share of around 25 percent by 2026. Which competing biosimilars will be preferred by payers, well a number of factors are expected to play a role, including concentration (high concentration likely to be preferred), pen-injector availability, manufacturer reputation, net costs, and supply chain security.

Humira has been a blockbuster of monstrous proportions – so it’s unsurprising that so many biosimilars manufacturers are looking for a piece of the pie. But over ten different products could mean a very small piece of pie for everyone. What’s your view on the matter? Please send me your thoughts.

Also on the topic of Humira, Vizient has released its Winter 2023 Pharmacy Market Outlook – which offers further commentary on Humira biosimilars. Of course, its stakeholders are eagerly looking forward to biosimilar competition for Humira, but does this mean prices are about to fall? Actually, Vizient expects inflation to push drug prices up by 3.78 percent. “Since the pandemic, we have seen a greater magnitude of higher prices. Although these values are much lower than the levels seen in the previous decade, the need for vigilance and action around medication use, and increasingly medication reimbursement, should remain a priority consideration for providers,” said Carina Dolan, Vizient assistant vice president of clinical oncology, pharmacoeconomics and market insights.