This is an important settlement as it resolves all Humira-related patent litigation in the US and provides access for another biosimilar manufacturer seeking to enter the US. Humira is claimed to be one of the world’s best-selling drugs, recording sales revenues of $4.9 billion globally in Q4 2018.
The patent dispute between AbbVie and Boehringer has been long-standing. In February this year, the US magistrate judge asked AbbVie to produce evidence that the company was obtaining patents that could shield Humira from biosimilar competition.
This settlement expands the number of drugmakers that have agreed to wait until 2023 to launch their biosimilar versions of Humira in the US, including Mylan, Novartis unit Sandoz and Pfizer.
Our exclusives in this issue on biosimilars in the US and EU, based on the presentations by Dr. Alexander Wittkopp, Hamm & Wittkopp, and Paul A. Braier, Greenblum & Bernstein, P.L.C., at CPhI’s Pharma IPR Conference, cannot be better timed than this.