First Adalimumab Biosimilar Launch in the USA

The first adalimumab biosimilar, Amjevita, has been launched in the USA by Amgen. Adalimumab (branded name Humira), which is indicated for a wide variety of rheumatic indications, is a blockbuster drug with $21.2 billion of sales in the US alone in 2022¹. Amjevita is launching in all of the same indications as Humira, with the exception of hidradenitis suppurativa

While this may be promising opportunity for cost-savings across the healthcare system, there are some potential hurdles. Amjevita is not launching with an interchangeability designation – this is something that Amgen are looking to obtain post-launch through a switching study. This could potentially affect uptake amongst prescribers unwilling to switch from reference to biosimilar. Additionally, Forbes reports that PBMs have indicated that Amjevita will launch on the same formulary tier as the originator biologic Humira; financial incentives to switch are therefore minimised².

Interestingly, the drug has been launched with two price points: one at a discount of 5% to list price of Humira and another at 55% discount (price of $1,557) to list price³. It has been speculated that rebates will be offered to pharmacy benefit managers (PBM) to encourage uptake of the higher priced option. Therefore, potential cost-savings aren’t passed onto the patients, who pay co-payments based on the list price of drugs. Amjevita is just one of eight adalimumab biosimilars launching this year, with wider biosimilar implementation a goal of the US government. This is reflected in specific biosimilar provision policies in the Inflation Reduction Act⁴

Sources:

1. https://www.reuters.com/business/healthcare-pharmaceuticals/abbvies-humira-gets-us-rival-costs-could-stay-high-2023-01-31/
2. https://www.forbes.com/sites/joshuacohen/2023/02/01/amgen-adopts-a-two-price-strategy-for-the-uss-first-marketed-humira-referenced-biosimilar-amjevita/
3. https://www.centerforbiosimilars.com/view/us-welcomes-first-adalimumab-biosimilar-amjevita
4. https://www.fiercepharma.com/pharma/nearing-watershed-year-biosimilars-industry-should-get-boost-new-measure-inflation-reduction