With billions in sales under threat, AbbVie is going all out in defense of its key drug and the world’s best seller, Humira. The company on Wednesday filed suit against rival Boehringer Ingelheim as that drugmaker advances a biosim with eyes on stealing market share.
In a new lawsuit in Delaware federal court, AbbVie says Boehringer wants to “reap the rewards” of its innovation on Humira, including on manufacturing and formulation work. AbbVie has more than 100 patents on Humira and has identified 74 it thinks Boehringer will infringe with a potential biosim launch.
Boehringer’s candidate Humira biosim is in phase 3 testing, according to the German company’s website. Humira brought in more than $16 billion last year for AbbVie, or 63% of the company’s total haul, a testament to how important that drug is for the Illinois drugmaker.
AbbVie says that even though the Biosimilar Price Competition and Innovation Act allows Boehringer a pathway to market for a copycat biologic, the law doesn’t allow patent infringement. Humira has been tested in more than 100 clinical trials and boasts indications in 10 diseases, according to AbbVie.
“In bringing Humira from the laboratory to patients, AbbVie operated in uncharted territory,” according to the lawsuit. “In 1996, AbbVie invented the antibody in Humira. But that was only the first step. Since then, AbbVie has embarked on two decades of research, investment, and innovation.”
AbbVie alleges “Boehringer seeks to copy the results of AbbVie’s clinical development.”
A Boehringer spokeswoman responded that the German company "does not comment on its biosimilars patent strategy or any ... patent litigation."
"We are confident in our biosimilar candidates and we will continue our efforts to make them available as therapeutic options to patients," she added.
This is just an initial lawsuit on eight patents, according to AbbVie. The Illinois drugmaker plans to sue on the others “if and when” Boehringer provides a 6-month marketing notice as required by the BPCIA. The company wants an injunction to stop Boehringer’s alleged infringement.
Boehringer's in-development biosim isn’t AbbVie’s only Humira threat, of course. Amgen already has an FDA approved copy, Amjetiva, although that drug hasn’t launched due to a separate patent lawsuit by AbbVie.
In fact, AbbVie CEO Richard Gonzalez has warned other drugmakers wanting to copy Humira "will have to contend with this extensive patent estate, which AbbVie intends to enforce vigorously." AbbVie contends its patents are valid until 2022.
That has not deterred a host of companies from deciding to take on the sales behemoth. Other companies with Humira biosims include Novartis’ Sandoz unit, Biogen and Fujifilm Kyowa Kirin Biologics. Each of those versions have advanced to regulators in Europe, according to press releases, where Amgen also boasts an approval. Merck and Coherus also have biosims in development.