adalimumab Archives - Medical Design Sourcing

AbbVie settles Humira-related litigation with Alvotech

AbbVie (NYSE:ABBV) has announced that it has resolved U.S. litigation related to Humira (adalimumab) involving Alvotech Holdings (Reykjavik, Iceland).

The two companies have reached an agreement that will give Alvotech a non-exclusive license to AbbVie’s Humira-related patents in the U.S. starting July 1, 2023.

Under the terms of the agreement, Alvotech will pay royalties to AbbVie to license Humira patents.

In 2020, Alvotech announced that the FDA was reviewing a biologics license application related to a proposed Humira biosimilar known as AVT02. In September 2021, FDA announced that it had delayed its review of the biosimilar candidate.

On February 28, Alvotech announced that FDA had accepted Alvotech’s biologic licensing application (BLA) for ATV02 with new data supporting interchangeability between ATV02 and Humira.

“We aim to be the first interchangeable, high-concentration biosimilar to this critical treatment,” said Robert We…

FDA approves first interchangeable Humira biosimilar to Humira

Last year, Humira (adalimumab) was the top-selling drug in the U.S., racking up nearly $20 billion in international sales.

Now, Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) has become the first interchangeable Humira biosimilar.

First winning FDA approval in August 2017, Cyltezo is a tumor necrosis factor blocker indicated for everything from arthritis to Crohn’s, ulcerative colitis and plaque psoriasis.

The FDA decided to grant interchangeable status to Cyltezo based on Phase 3 randomized VOLTAIRE-X clinical trial.

FDA allows interchangeable biosimilars to be substituted for the reference product without the prescriber modifying the prescription.

“We are proud to be the company driving the advancement of biosimilars and delivering the first and only Interchangeable biosimilar with Humira,” said Thomas Seck, senior vice president, medicine and regulatory affairs at Boehringer Ingelheim, in a statement. “The Interchangeability status of …

AbbVie accuses Alvotech of stealing Humira trade secrets

In a complaint filed in Illinois federal court, AbbVie alleges that the Icelandic biopharma company Alvotech sought to copy its blockbuster biologic Humira (adalimumab).

The lawsuit accuses Alvotech of hiring a former AbbVie employee, Rongzan Ho, to help it develop a copycat version of Humira.

Ho, a team leader of upstream manufacturing for Humira, was well-versed in the processes involved in manufacturing the drug.

Ho relayed to AbbVie in an exit interview that he was leaving “mainly to learn single-use bioreactors and other new technologies.”

Ho left AbbVie in 2018 to join Alvotech and provided the company with proprietary spreadsheets, according to the complaint, which also accuses Alvotech of poaching other former AbbVie employees.

In November, Alvotech announced that the FDA had accepted its biologics license application to review its proposed Humira biosimilar. “AVT02 is highly similar to its reference product in terms of structu…