Drugs: Pharma, PBMs and Pharmacies

Humira, an injected antibody for rheumatoid arthritis and other autoimmune diseases, became the best-selling drug in the world. Its main US compound patent expired in December 2016. In Europe biosimilar copies arrived in October 2018, and some health systems' tenders cut the price by 80% or more (reported). In the US they arrived on 31 January 2023. The difference was a patent estate. AbbVie, which owned Humira, had told investors since 2013 that it would not face US biosimilar competition before 2022 at the earliest, citing more than 100 additional patents on formulations, manufacturing and methods of use; the advocacy group I-MAK counted about 130 or more granted US patents (reported). AbbVie settled with Amgen in September 2017 and then with every other biosimilar developer, giving them licences to sell in Europe from 2018 and in the US from 2023. Humira's sales peaked at about $21 billion in 2022. Between composition-patent expiry and US biosimilar entry, it earned roughly $93 billion of US revenue (sum of annual 10-K figures, approximate), time that AbbVie used to build its successors, Skyrizi and Rinvoq, and to buy Allergan for about $63 billion. A payer antitrust suit was dismissed, a decision affirmed on appeal in 2022.

Even after biosimilars launched, they gained little share in their first year, because high-list, high-rebate Humira remained attractive to pharmacy benefit managers. That changed in April 2024 when CVS Caremark removed Humira from its major formularies in favour of biosimilars, including one sold through its own subsidiary, Cordavis. A drug's US economics are decided not only in the laboratory and the patent office but at the PBM, and this chapter follows the money through all three.