Helping you make wiser investment decisions

Alvotech scores in AbbVie trade secrets case, but the Humira patent fight will stretch into next year

October 7, 2021 Eric Sagonowsky


Even as many biosimilar companies await their agreed-upon launch dates for their versions of the world’s bestselling drug—AbbVie’s Humira—Alvotech is still busy battling the drug giant in court. This week, the company scored a big win.

In a Wednesday decision, a federal judge in Illinois dismissed AbbVie’s trade secrets theft lawsuit against Alvotech. Previously, AbbVie sued Alvotech arguing the Icelandic company recruited one of its manufacturing execs, Rongzan Ho, who emailed himself “confidential and proprietary” information about Humira’s manufacturing just before leaving.

When Ho joined Alvotech, he led manufacturing for the company’s proposed biosimilar AVT02, AbbVie said in its suit.

But this week, Judge Harry D. Leinenweber threw the case out for lack of jurisdiction, the filing shows.

While the decision marks a win for Alvotech, the company has a long way to go before it can launch its proposed biosimilar in the lucrative U.S. market. The development comes amid a bitter patent fight between the drugmakers and as Alvotech seeks an FDA approval.

RELATED: AbbVie says biosim maker Alvotech recruited a manufacturing exec to steal trade secrets on Humira

In the patent lawsuit, the Illinois federal court recently said it plans to rule “by the end of October of 2022.” In a filing last month, the court said Alvotech “agreed not to launch AVT02 in the United States prior to the issuance of the court’s decision.” The court has scheduled a trial for August 2022.

That means AbbVie and Alvotech will likely be fighting over Humira patents for another year. Meanwhile, the biosimilar company is hoping to score an FDA approval and a coveted interchangeability tag for its product.

Alvotech says it’s the only known company that has submitted an FDA application for a high-concentration Humira biosimilar and that has completed a switching study in pursuit of an interchangeability designation. That tag would allow pharmacists to substitute Alvotech’s biosimilar for the branded AbbVie blockbuster at the pharmacy counter.

But the biosim developer hit a regulatory snag last month when the FDA delayed a regulatory decision on AVT02 until it can complete manufacturing site inspections. Since the start of the COVID-19 pandemic, several biopharma companies have been hit by travel restrictions that put off timely FDA site inspections.

Just a couple of weeks before that FDA delay, Alvotech said its product succeeded in a Humira switching study. That study showed patients can switch between the branded drug and the biosimilar and still expect the same efficacy and safety.

RELATED: Alvotech, not content to line up behind other Humira biosims, sues AbbVie over ‘wrongful monopoly’

As Alvotech works through the regulatory and legal issues, several biosimilar companies are already lined up to launch their versions of Humira in 2023. Currently, Amgen is set to kick off the competition with a January 2023 launch, followed by other major players such as Viatris, Novartis’ Sandoz, Samsung Bioepis and more.  

When Boehringer Ingelheim—which previously set out to fight AbbVie’s Humira patents in court—inked its own settlement in May 2019, the company became the eighth biosimilar rival to strike a deal with AbbVie.

AbbVie’s Humira generated nearly $20 billion in 2020, despite the fact that biosimilars are currently eating market share in Europe. Alvotech is partnered with Teva for a U.S. launch of its product.



Source link