Settlement Opens Doors for Biosimilars of AbbVie’s Most Profitable Drug

 

Pharma giant AbbVie and Iceland-based Alvotech have settled a case filed with the International Trade Commission. The dispute centered around Alvotech’s adalimumab biosimilar drug, which AbbVie posited had been developed through theft of trade secrets of its Humira® product.

While the companies did not say how much money the settlement involved, the litigation did open legal doors for more Humira biosimilars to be manufactured by other companies in the future.

The drug Humira (adalimumab) treats a variety of immune diseases, such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis and psoriasis. Many of these diseases have no other treatments besides Humira. In fact, Humira is the only U.S. Food and Drug Administration (FDA)–approved medicine for moderate to severe hidradenitis suppurativa, a chronic inflammatory skin disease that creates sores all over the body.

The drug was launched in 2003. Since then, it has become the highest-grossing pharmaceutical product in the world, aside from COVID-19 vaccines. AbbVie’s Humira sales topped a massive $20.7 billion in 2021. Now, those profits face cuts with a potentially-approved competitor biosimilar drug to launch in the United States in 2023.

For decades, AbbVie has maintained an iron-grip monopoly on its cash cow drug. In 2018, lawsuit settlements allowed biosimilars to be marketed in Europe and Japan, but those same settlements also caused significant delays in bringing any Humira biosimilar to the market in the U.S. This was a move motivated by money, as $16 billion of Humira’s global $20 billion+ sales come from the U.S. alone.

Alvotech, a company dedicated to making high-quality biosimilars to make medicines more affordable, began working on a biosimilar to Humira called AVT02. The new biosimilar drug worked marvelously well: when treating patients who had previously been treated with Humira, AVT02 produced the same levels of clinical efficacy, safety and immunogenicity. Alvotech partnered with Teva Pharmaceuticals, a company dedicated to making generic medications, to help commercialize the new drug.

To be considered a biosimilar product, the drug must meet all requirements of the Biologics Price Competition and Innovation Act. This includes requiring the company to show proof of the same clinical results as the marketed product in any given patient. The safety and risks must also be the same. Alvotech’s AVT02 met all the requirements.

Despite the positive product data, Alvotech faced legal trouble bringing its product to market. AbbVie has long maintained a monopoly on Humira, and Alvotech filed a federal lawsuit to end the monopoly. AbbVie fought back and slammed Alvotech with more than 60 patent claims to try and discourage any competitor’s progress. In December 2021, AbbVie brought the case to the U.S. International Trade Commission, alleging theft of trade secrets.

In November 2020, the FDA accepted Alvotech’s Biologics Licensing Application (BLA). However, due to AbbVie’s lawsuits, the FDA deferred action.

But Alvotech was not deterred. In September 2021, AVT02 received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the of the European Medicines Agency’s (EMA) on AVT02.

Finally, in February 2022, the FDA accepted Alvotech’s Biologics Licensing Application (BLA) for review for AVT02. The FDA said that it will reach a decision by December 2022.

Now, the final barrier – the lawsuit from AbbVie – has been removed. The resolution grants Alvotech a non-exclusive license to all Humira-related patents in the United States beginning on July 1, 2023. AbbVie will not pay anything to Alvotech, but Alvotech will pay royalties to AbbVie for licensing its Humira patents. The International Trade Commission has dismissed all patent and trade secret litigation.

This is a huge win for Alvotech, but it’s also a game-changer for the world of biosimilars. AVT02  could become the second-ever biosimilar to enter the U.S. market. It would come in behind Amgen’s Amjevita, another biosimilar for adalimumab, and Samsung Bioepis’ Hadlima. All of these biosimilars are expected to hit the market in 2023.  The more biosimilars that hit the market, the more affordable the drugs become. The litigation proved that monopolies on profitable drugs can be broken, providing financial relief to millions of patients.

“Our new product will be a gamechanger that will provide consumers who are suffering from chronic pain with significant savings, and we look forward to bringing this drug onto the market as soon as possible,” said Alvotech founder and chairman Robert Wessman.