No Easy Path to Market for Alvotech's Adalimumab Biosimilar

Reykjavik, Iceland–based biosimilars company Alvotech is treading a topsy-turvy path toward biosimilar marketing.

The company hopes to be the first to market in the United States with an adalimumab (Humira) biosimilar, for the treatment of autoimmune and inflammatory conditions, such as rheumatoid arthritis. However, the originator company, AbbVie, is not making it easy.

Humira is the top-selling drug in the world, with more than $20 billion in revenues in 2020, which means AbbVie has a huge stake in retaining product exclusivity protections as long as possible. Every additional month without competition in the United States potentially means as much as $1 billion or more in sales. Humira notched $16 billion alone in US sales in 2020.

Alvotech is something of an upstart among companies that seek to bring adalimumab biosimilars to market. In the United States, 6 companies have received FDA approvals to market adalimumab biosimilars, but each has settled with AbbVie to bring their products to market no sooner than 2023.

Alvotech hopes through an ongoing court action to overturn several key patent protections for Humira and thus gain access to the US market as soon as October 2022. The company has developed a citrate-free, high-concentration (100 mg) formulation of adalimumab that may also qualify for interchangeable status, giving pharmacists more latitude to dispense this product than they would have otherwise.

But separately, the 2 companies are locked in a battle over trade secrets used in the manufacture of Humira. AbbVie claims Alvotech took a shortcut in the development of its biosimilar candidate (AVT02) by using purloined manufacturing data it obtained from a former AbbVie employee.

In October, an Illinois District Court judge declined to hear an AbbVie casing involving the alleged theft of trade secrets. That dismissal resulted because Judge Harry D. Leinenweber determined the court did not have jurisdiction over what AbbVie asserted was the theft of trade secrets from its Singapore offices for use in Iceland.

In a second-try filing, AbbVie has appealed to the US International Trade Commission with an argument that by manufacturing product with the alleged stolen data and importing that product to the United States, for the purposes of FDA review, approval, and eventual commercialization, Alvotech is wrongfully using trade secrets and disrupting AbbVie’s exclusive market for Humira in the United States.

“AVT02 will undercut Humira significantly on price and unfairly compete, leading to lower revenue, lower profits, reduced return on investment and, as a result, significant injury to the industry that AbbVie has invested in significantly to develop in the United States,” AbbVie wrote in the complaint.

For its part, Alvotech maintains that these latest allegations of trade secret theft are groundless. The company cited a more-public dispute between AbbVie and the biosimilars-legislative community that the pharmaceutical giant has improperly extended the life of its Humira franchise by creating a web of patents that effectively deters attempts at competition in the United States.

“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,” Alvotech said in a statement. “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.”

The court battles are playing out as Alvotech positions itself to bring its first biosimilar product to market. Adalimumab so far has been its showcase product candidate, as it is furthest along in development and regulatory approval.

The product received approval for marketing in the European Union on November 15, 2021. A ruling by the FDA on the product’s marketability has been delayed by that agency’s need to complete manufacturing facility inspections.

Partly on the strength of its adalimumab marketing potential, Alvotech succeeded recently in lining up $450 million in additional investor money from a consortium of companies, and an initial public offering is planned at an undisclosed future date, the company has said.

The company also has an ustekinumab (Stelara; plaque psoriasis, psoriatic arthritis) biosimilar under clinical stage development and has formed a large number of partnerships with other companies to facilitate international sales once regulatory approvals for these biosimilar candidates are secured.