Photo courtesy of AbbVie Inc.
Pharmaceutical giant AbbVie and based in Iceland Alvotech to have settled a case filed with the International Trade Commission. The dispute centered on Alvotech’s biosimilar drug adalimumab, which AbbVie claims was developed through the theft of trade secrets from its Humira® product.
Although the companies did not specify the amount the settlement involved, the litigation opened legal doors for more Humira biosimilars to be made 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 apart from Humira. In fact, Humira is the only American Food and Drug Administration (FDA)–approved drug 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 most profitable pharmaceutical product in the world, except for COVID-19 vaccines. AbbVie’s Humira sales exceeded a huge $20.7 billion in 2021. Now those profits face cuts with a potentially approved competing biosimilar drug launching in the United States in 2023.
For decades, AbbVie maintained an iron monopoly on its cash cow medicine. In 2018, trial settlements authorized the commercialization of biosimilars in Europe and Japan, but these same agreements also caused significant delays in bringing any Humira biosimilars to market in the United States. alone.
Alvotech, a company dedicated to making high-quality biosimilars to make drugs more affordable, has started work on a biosimilar to Humira called AVT02. The new biosimilar drug worked wonderfully well: When treating patients previously treated with Humira, AVT02 produced the same levels of clinical efficacy, safety and immunogenicity. Alvotech has partnered with Teva Pharmaceuticalsa company dedicated to manufacturing generic drugs, to help bring the new drug to market.
To be considered a biosimilar, the drug must meet all requirements of the Biologics Price Competition and Innovation Act. This notably implies requiring the company to provide proof of the same clinical results as the product marketed in a given patient. Safety and risk should also be the same. Alvotech’s AVT02 met all the requirements.
Despite the positive data on the product, Alvotech encountered legal problems in bringing its product to market. AbbVie has long maintained a monopoly on Humira, and Alvotech filed a federal lawsuit to end the monopoly. AbbVie retaliated and criticized Alvotech with over 60 patent claims in an attempt to discourage any competitor’s progress. In December 2021, AbbVie took the case to the United States International Trade Commission, alleging trade secret theft.
In November 2020, the FDA has accepted Alvotech’s Biologics License Application (BLA). However, due to AbbVie’s lawsuit, the FDA deferred action.
But Alvotech was not discouraged. In September 2021, AVT02 has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on AVT02.
Finally, in February 2022, the FDA accepted Alvotech’s Biologics License Application (BLA) for review for AVT02. The FDA said it would make a decision by December 2022.
Now the final hurdle – the AbbVie lawsuit – has been removed. The resolution grants Alvotech a non-exclusive license to all Humira-related patents in the United States effective July 1, 2023. AbbVie will not pay Alvotech anything, but Alvotech will pay royalties to AbbVie for licensing its Humira patents. The International Trade Commission dismissed all patent and trade secret disputes.
This is a huge win for Alvotech, but it’s also a game-changer for the world of biosimilars. AVT02 could become the second biosimilar to enter the US market. He would come behind Amgen‘s Amjevita, another adalimumab biosimilar, and Samsung Bioépis’ Hadlima. All of these biosimilars are expected to hit the market in 2023. The more biosimilars hitting the market, the more affordable the drugs become. The litigation has proven that monopolies on profitable drugs can be broken, bringing financial relief to millions of patients.
“Our new product will be a game-changer and provide consumers with chronic pain with significant cost savings, and we look forward to bringing this drug to market as soon as possible,” noted Alvotech founder and president, Robert Wessman.