Humira (adalimumab) marketing authorisation holder, AbbVie, has signed a non-exclusive patent license for Pfizer to market a biosimilar version of the blockbuster drug in a number of countries worldwide, including the US.
Per the agreement, and upon approval by the US Food and Drug Administration, Pfizer’s adalimumab candidate may launch on November 20, 2023. Financial details of the license agreement were not disclosed.
Pfizer confirmed the development programme for its investigational Humira biosimilar is complete; however, spokesperson Thomas Biegi told us he “cannot comment further on [its] timeline for regulatory filings.”
US competition
Tumour necrosis factor (TNF)-inhibitor Humira is indicated to treat several chronic conditions, including rheumatoid arthritis, inflammatory bowel disease and psoriasis.
The blockbuster drug, which brought in $18bn (€15.8bn) in global sales last year, has attracted significant attention from drugmakers looking to acquire a share of Humira’s revenue.
In the US, AbbVie has secured patent protection for another five years via similar license agreements with drugmakers including Amgen, Samsung Bioepis, Mylan, and Sandoz.
European focus
The licence agreement also authorises Pfizer to launch a Humira biosimilar in Europe – where AbbVie’s patent protection expired on October 16 of this year.
Upon regulatory approval by the European Medicines Agency, Pfizer’s Humira biosimilar will join Amgen’s Amgevita, Sandoz’s Hyrimoz, Samsung Bioepis’ Imraldi, and Mylan’s Hulio on the European market.
These same drugmakers recently negotiated deals with NHS England, enabling patients currently taking Humira to switch to ‘low cost versions’ within 12 months.