Alvotech latest to challenge AbbVie on US Humira exclusivity

AbbVie is confident that no biosimilar will challenge Humira sales in the US until 2023 despite a legal challenge from Alvotech seeking to end the monopoly.

Humira (adalimumab) is the world’s top selling drug, pulling in $19.8 billion in revenues for AbbVie in 2020. Of this, $16.1 billion was from the US, a region currently protected from adalimumab competition due to AbbVie’s web of patents and legal agreements with numerous biosimilar makers.

But while the likes of Amgen, Samsung Bioepis, and Sandoz settled to keep their respective products away from the US market until 2023, Iceland-based drugmaker Alvotech filed a federal lawsuit earlier this month seeking to end AbbVie’s monopoly.

Image: iStock/martince2

Alvotech, which has filed its own adalimumab biosimilar AVT02 with the US Food and Drug Administration (FDA), alleges that AbbVie “seeks to overwhelm Alvotech with 60+ patent claims of questionable validity in order to keep its closest competitor off the market, a tactic it has long used against other competitors.”

The firm accuses AbbVie of taking “several improper steps to inflate its patent portfolio,” including “patenting purported inventions that it does not use in the production of Humira; seeking multiple patents on the same invention but as part of different patent families in a manner designed to cause confusion; [and] obtaining patents through inequitable conduct.”

These issues were brought up during a House Committee on Oversight and Reform hearing examining the pricing and business practices of AbbVie on May 18. The Committee expressed “bipartisan outrage after internal documents revealed that AbbVie originally projected it would face competition from lower-priced biosimilar versions of Humira in 2017, but employed legally questionable tactics to delay American patients access to biosimilars until 2023.”

But despite this, AbbVie says it has done nothing wrong and does not expect to see US biosimilar competition until at least 2023.

“We remain very confident in the IP that we have generated around Humira, we think it represents true innovation and many years of investment,” Michael Severino, vice chairman and president, told delegates at the UBS Global Healthcare Virtual Conference yesterday.

“This is IP that in many instances has been challenged and upheld multiple times. So we feel very confident in its validity. And that view has not changed. In our view 2023 is the time period for entry of biosimilars into the US market.”