AbbVie, after losing Humira trade secrets case, eyes new strategy in Alvotech fight

AbbVie is taking a different tack in its fight with Alvotech over the Icelandic company's Humira biosimilar program, this time asking trade officials to block imports. 

In a recent complaint filed at the U.S. International Trade Commission (ITC), AbbVie said Alvotech has "misappropriated" trade secrets linked to the production of its Humira copycat. As a result, the ITC should bar imports or sales of the biosim in the U.S., lawyers for AbbVie argued in the complaint. 

The move wouldn't hamper public health, AbbVie argued, because the company "alone" can meet demand for the blockbuster immunology medicine in the U.S. What's more, the first slate of U.S. Humira biosimilars are poised to debut starting in late January 2023, so it isn't as if AbbVie will be the sole provider of the drug for much longer, the company noted.

AbbVie earlier this year filed suit against Alvotech, accusing the company of recruiting an employee who purloined confidential documents on Humira's manufacturing shortly before he switched jobs. In October, a federal judge in Illinois tossed the case on lack of jurisdiction. AbbVie is appealing the decision. 

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In its ITC case, AbbVie argued that a crackdown on the biosim player would serve the public interest by sticking up for its intellectual property rights. It would also stop Alvotech from "[cutting] in line" ahead of other drugmakers "who have independently developed their own manufacturing processes without the use of AbbVie's trade secrets."

Alvotech, for its part, rejected its rival's arguments in an emailed statement.

“This action by AbbVie–which repackages the meritless allegations from a case that was thrown out of court earlier this year–is a sign of AbbVie’s weakness and concern that Alvotech’s efforts to bring a lower-cost offering to market will expose AbbVie’s long-standing abuse of the patent/legal system," Robert Wessman, founder and chairman of Alvotech, said over email.

Alvotech has made a slightly unique claim with regards to its biosim program. The company argues its version of the drug is the first-filed copycat equal in strength to Humira's latest formulation, which AbbVie markets as a high-concentration, pain-free version of the drug. Alvotech has also completed a switching study in hopes of snaring a coveted interchangeability tag for its med, which would allow pharmacists to substitute Alvotech's product for brand-name Humira at the pharmacy counter. 

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The biosim player still needs FDA approval before it can launch its biosim. It also needs to await the final decision in a patent feud, which is expected to read out by October 2022. 

"In line with the House Oversight Committee’s findings earlier this year, AbbVie’s abuse has improperly extended its monopoly well beyond even its own internal expectations. Alvotech remains undeterred in our mission to bring an affordable Humira biosimilar to patients as soon as possible," Alvotech's Wessman continued.

In the U.S., Amgen is set to kick off the Humira biosimilar spree on Jan. 31, 2023. Boehringer Ingelheim and Pfizer have agreed to launch their versions of the med on July 1, 2023, and Nov. 20, 2023, respectively. A host of other companies are set to launch throughout the year.

Meanwhile, Alvotech recently telegraphed its plans to go public via a special purpose acquisition company (SPAC) deal. The pact, which is expected to close in the first half of 2022, puts Alvotech in line for $450 million in cash. 

Editor's note: This story has been updated with comments from Alvotech.