Alvotech deal could heighten biosimilar pressure on Humira

Dive Brief:

• Alvotech and U.S. commercial partner Teva have signed a “long-term agreement” with an unspecified company to boost access to their biosimilar version of AbbVie’s blockbuster drug Humira, Alvotech said Friday. An Alvotech spokesperson declined to provide specifics.
• The deal comes seven weeks after the Food and Drug Administration approved Alvotech’s biosimilar, Simlandi, which the agency previously rejected multiple times. For patients to receive treatment, Alvotech and Teva must first cut deals with drug wholesalers, pharmacies and insurers that negotiate prices before agreeing to cover the therapy.
• CVS Health, whose pharmacy benefit manager is the country’s largest by prescription claims, removed Humira from its national formulary on April 1. Wall Street analysts have already reported substantial declines in Humira prescriptions over the last few weeks, when compared to the same period in 2023.

Dive Insight:

Alvotech’s stumbles in winning approval of Simlandi put the company at a significant disadvantage, as the drug’s clearance came 13 months after Amgen’s Amjevita, the first Humira biosimilar, got to market. But Simlandi has on its side so-called interchangeability status, which allows pharmacists to substitute it directly without needing a doctor’s approval. It’s also the same formulation of the most popular version of Humira.

Those attributes could help insurers looking to move away from branded Humira, though “we do not know if any other major payers will effect a hard switch in the future, like CVS has done,” wrote Leerink Partners analyst David Risinger, in a Friday note to investors.

So far, the biggest winner in the battle for market share appears to be Sandoz’ Hyrimoz, which is being co-marketed through a CVS subsidiary called Cordavis. Citing data supplied by analytics company Iqvia, analysts from Deutsche Bank wrote that 15% of the total prescriptions for adalimumab, Humira’s scientific name, were credited to Cordavis’ product for the week ending April 12. No other biosimilar claimed more than 2%, according to Deutsche Bank.

Humira’s share shrank from 96% for the week ending March 29 to 81% the week ending April 12, the analysts wrote.

Global Humira revenue fell 32% to $14 billion last year. The company will give its latest glimpse at Humira sales on April 26, when it reports first quarter results. Wall Street analysts will likely ask whether AbbVie’s previous guidance, predicting a 36% U.S. sales decline for Humira in 2024, needs to be revised, Leerink’s Risinger wrote.

The Alvotech spokesperson said the company would be making further statements on its partnership in about four weeks.

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