Late last week, Amgen and AbbVie settled litigation over when competition for the world’s best-selling biologic Humira (adalimumab) will hit the market, and for the US, the settlement decided on 31 January 2023, while the EU will see competition 16 October 2018.
The deal between the two companies means that AbbVie’s Humira, which was first approved by FDA in 2002 and accumulated sales of more than $130 billion in its first 15 years on the market, will be on the US market for more than 20 years with no competition.
The reason for the delay to 2023 in the US is largely the result of a fortress of patents on Humira. While the composition of matter patent covering Humira expired in December 2016, AbbVie said earlier in 2017 that non-composition of matter patents covering Humira expire no earlier than 2022.
The discrepancy between the US and EU launch dates reveals a widening gap between how the two regions are adopting biosimilars, with the EU bringing biosimilar competition faster and more consistently to market, while the US has seen delays and when biosimilars do come to market for blockbusters in the US, at least one has faced challenges in capturing market share.
CMS Spend on Humira
But this latest deal between Amgen and AbbVie will likely cost the US Centers of Medicare and Medicaid (CMS) at least $1.48 billion.
That ballpark figure is the result of a look into the 2015 Medicare Part B and Part D spend on Humira ($1,662,291,827 total) and 2015 Medicaid total spend on Humira ($805,458,621).
If just one competing biosimilar was marketed from 2019 until 2023 (like in the EU) and the total CMS spend on Humira was reduced by 15%, the total spend would be reduced by $1.48 billion.
And that 15% figure does not account for the fact that two Humira biosimilars have already been approved by the US Food and Drug Administration (FDA) – Amgen’s Amjevita (adalimumab-atto) in September 2016, and more recently in August, FDA approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) - although prices on biologics have not fallen as dramatically when biosimilars are introduced as in the generic drug space and generally not without multiple entrants.
And the EU is seeing multiple competitors vying for a share of Humira’s billions. The EU could end up seeing more than five Humira biosimilars (Amgen, Pfizer, Boehringer, Novartis’ Sandoz, Samsung Bioepis and Biogen and Fujifilm Kyowa Biologics) before the US sees one.
Editor's note: Article updated with Boehringer's four-letter suffix for Cyltezo. It is adbm, not atto. Atto is the four letter suffix for Amgen's Amjevita.