- Alvotech’s Proposed Interchangeable Product for High-Concentration Humira® Could Save U.S. Consumers and Taxpayers Billions Annually
- In May of 2021, Alvotech USA Inc. Sued to End AbbVie’s Wrongful Monopoly on Humira and Bring an Affordable Arthritis Treatment to the U.S. Market
Alvotech, today, announced reaching the primary completion date in the switching study for AVT02, the company’s proposed interchangeable biosimilar to Humira®. The purpose of the switching study (AVT02-GL-302) is to support the approval of AVT02 in the U.S. as an interchangeable biosimilar product with the high concentration (100mg/mL) dosage forms of Humira®. Alvotech is the only known company that has both developed a biosimilar candidate for the high-concentration Humira® and is executing a switching study to support approval as an interchangeable product. Top-line results from the switching study are expected later this year.
For 2020, AbbVie reported global revenues for Humira® of nearly $20bn, of which more than $16bn came from the U.S. market. Today, over 80% of the usage of Humira® in the U.S. uses the high concentration form.
In November of 2020, the U.S. Food and Drug Administration and European Medicines Agency accepted Alvotech’s regulatory submissions for AVT02. A decision from the FDA regarding the company’s Biologics License Application (BLA) for AVT02 is expected in September of 2021 and an EMA decision for the AVT02 European Marketing Authorization Application (MAA) is anticipated in the fourth quarter of 2021.
In May 2021, Alvotech USA Inc. filed a lawsuit in the Eastern District of Virginia seeking to invalidate four of AbbVie’s key patents. The lawsuit also argues that AbbVie’s patent strategy, which has been under recent Congressional scrutiny, renders its Humira® patents unenforceable. Further, the lawsuit points out that AbbVie has failed to sue Alvotech’s US affiliate (the actual BLA applicant) at all. At stake are billions of dollars of cost to the U.S. healthcare system, negatively impacting consumers and taxpayers.
The FDA describes biosimilar interchangeability as follows: “Once such medications are FDA approved and available in the United States, they may be substituted at the pharmacy without the intervention of the health care professional who prescribed it, much like how generic drugs already are routinely substituted for brand name drugs.” (see here).
The concept of interchangeability for biosimilars was signed into law through the Biologics Price Competition and Innovation Act (BPCIA) in 2010. In order to be considered interchangeable, a biosimilar must meet additional requirements, including the execution of an interchangeable “switching study”, utilizing the innovator and biosimilar product in patients. The vast majority of states have passed laws regarding substitution for interchangeable biosimilars.
AVT02-GL0302 is a multicenter, randomized, double-blind, parallel-group study to evaluate PK, efficacy, safety, and immunogenicity between patients receiving Humira and patients undergoing repeated switches between Humira and AVT02, followed by an optional safety Extension Phase. The study is composed of 3 phases: (1.) a lead-in phase, where all patients receive Humira; (2.) a switching phase, where one cohort receive Humira and one cohort switches between AVT02 and Humira; and (3.) an optional open-label extension phase, where all patients receive AVT02. The study enrolled 568 participants. The primary completion date occurs at the end of the second phase (at week 28), in which the last participant is examined to collect final data for the primary outcome measures.