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Alvotech, battling AbbVie over its Humira biosim, raises $450M and tees up Nasdaq debut

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Alvotech, the biosim specialist locked in a legal battle over AbbVie’s sales Goliath Humira, is revving up for its debut on the Nasdaq.

The Icelandic company is joining forces with a special purpose acquisition company (SPAC) sponsored by an affiliate of Oaktree Capital Management, Alvotech said Tuesday. The deal immediately puts Alvotech in line for $450 million in new cash and tees up the company’s Nasdaq launch under the “ALVO” tag. 

Alvotech’s plans to go public come shortly after the company escaped a Humira trade secrets theft lawsuit. AbbVie had accused Alvotech of recruiting one of its manufacturing executives, who allegedly emailed himself “confidential and proprietary” information about Humira’s production just before his departure from the Big Pharma. In October, a federal judge in Illinois scrapped the case for lack of jurisdiction, court documents filed that month show. 

Separately, Alvotech has sued AbbVie in hopes of ending the pharma juggernaut’s “wrongful monopoly” on the world’s best-selling drug, Humira. In that case, Alvotech has accused AbbVie of deploying a “patent thicket” around the drug to keep lower-cost rivals off the market. Alvotech asserts that its biosim is the first-filed copycat equal in strength to the latest version of Humira, which AbbVie markets as a high-concentration, pain-free version of the med. The company has also completed a switching study in hopes of scoring an interchangeability tag. 

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The first biosim challengers to Humira are set to roll out in 2023, with Amgen at the front of the pack.

Under Tuesday’s SPAC deal, which is expected to close in the first half of 2022, Alvotech is set to receive $450 million in cash. Of that, $250 million will come from Oaktree Acquisition Corp II’s coffers, while $150 million will come from new private investors and $50 million will come from current Alvotech shareholders, the company said in a release. The transaction has won the full blessing of both Alvotech and the SPAC trust’s boards. 

After the transaction, Alvotech is expected to have an implied initial value of $2.25 billion and will be “well-positioned” to continue pumping cash into its biosimilar pipeline, the company said. Aside from its Humira copycat, Alvotech is advancing biosimilars for Johnson & Johnson’s Stelara and Simponi, Regeneron’s Eylea and Amgen’s Prolia/Xgeva.

As Humira nears a 2023 patent cliff, the medicine continues to pull in megablockbuster sales, reaping nearly $20 billion last year. Meanwhile, biosimilars are already stealing market share in Europe and Japan.

RELATED: AbbVie’s ‘unsupported’ price hikes on Humira drove $1.4B in extra U.S. drug spending, ICER says

In the U.S., Amgen is set to kick off the Humira biosimilar parade on Jan. 31, 2023. Boehringer Ingelheim and Pfizer have agreed to launch their biosimilars on July 1, 2023, and Nov. 20, 2023, respectively. 

In Boehringer’s case, the company has won a coveted “interchangeability” tag. This means its product could eventually be substituted for Humira at the pharmacy counter. Other biosimilars need a specific prescription.

Alvotech is also pursuing interchangeability designation on its drug, and it recently completed a successful switching study to further that ambition. Meanwhile, the company is partnered with Teva on the U.S. launch of its biosim, while it’s teamed up with Stada in Europe.

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