- The Food and Drug Administration is reviewing Alvotech’s newest application for its Humira biosimilar, setting a Feb. 24 deadline to decide on approval, the company said Wednesday. The regulator has twice rejected the drug because of manufacturing issues at an Iceland plant.
- Alvotech said its latest approval application contains additional information on the methods used to measure quality and consistency at that plant to “address manufacturing facility deficiencies identified earlier by the FDA.”
- If the decision is positive, the Iceland-based drugmaker will be more than a year behind the first U.S. Humira biosimilar launched by Amgen and seven months behind a wave that hit the market at mid-year. Alvotech had been banking on its product being one of the first “interchangeable” Humira biosimilars — meaning it can be substituted by pharmacists — although that advantage could diminish by the time it launches.
The expiration of AbbVie’s key patents on Humira earlier this year has led to a rush of biosimilar makers hoping to grab a share of the $18.6 billion in U.S. sales it recorded last year. Alvotech, which is partnered with generics giant Teva, was in the running for a slice of that revenue until regulatory hurdles got in the way, exacerbated by the FDA’s inability to complete plant inspections during the COVID-19 pandemic.
The initial setback came a year ago, when the FDA first identified manufacturing deficiencies. At the time, Alvotech said it intended to resolve the problems by December 2022, by which time a separate approval application seeking “interchangeability” was supposed to have a verdict from the FDA.
In April, the FDA again rejected Alvotech's main approval application, based on deficiencies it spotted during a March inspection. And for good measure, it also knocked down the company's second attempt at an interchangeability approval just before it had the legal right to launch its biosimilar on July 1.
Missing out on that revenue stream meant Alvotech needed to raise money. It would go on to bring in $140 million from Teva and other investors and other investors while also stepping up its involvement in getting the Iceland plant FDA-compliant.
Alvotech is leaning heavily on its possible status as the only high-concentration interchangeable Humira biosimilar. Boehringer has won interchangeability status for its low-concentration drug named Cyltezo and Pfizer could earn the same status for its low-concentration biosimilar, called Abrilada, by the end of the year.
In the meantime, big pharmacy benefit managers have already made deals with other biosimilar makers, increasing Alvotech’s entry challenges. Cigna Healthcare’s Express Scripts and United Healthcare’s Optum have chosen Cyltezo, Amgen’s Amjevita and Novartis’ Hyrimoz, along with an unbranded Novartis biosimilar.
CVS Health, meanwhile, has chosen a private label version of Hyrimoz and has also announced its intention to become more deeply involved in biosimilar commercialization.