The copycats chasing Humira’s tail

On January 31 Amgen launches the first Humira biosimilar in the US, under an agreement struck with Abbvie back in 2017 that gave it a six-month head start on other copycats. The value of this lead to Amgen is hard to calculate – the terms of that deal were undisclosed, though royalty payments and possibly an up-front fee were involved. In any case, until 2024 there will be little incentive for switching, SVB analysts note, as formularies that included Humira biosimilars in 2023 did not give these products any advantages. Mid-2023 will see several others enter the market, and at this point differentiators could start to matter. Abbvie’s Humira is mostly sold as a high-dose concentration of active ingredient, and only Alvotech and Teva’s product, AVT02, can match this; that product’s FDA approval is still pending, however. Interchangeability is another important factor. Alvotech and Teva are gunning for this, as is Pfizer; Amgen and Organon are a bit behind here, though the former has indicated that it might achieve this later this year. By 2028 Humira biosimilars could be selling $2.8bn, according to Evaluate Pharma's consensus, with Amgen's Amjevita accounting for almost half of this number.