- Alvotech and Teva won’t launch their copycat version of AbbVie’s inflammatory disease drug Humira as planned in July after the Food and Drug Administration once again cited manufacturing issues at a plant in Iceland.
- The FDA issued a complete response letter on Alvotech’s application to market its product, AVT02, as “interchangeable” with Humira. The designation is coveted by biosimilar makers because it allows pharmacists to substitute the copycat version for the branded product without involving the original prescribing doctor.
- Regulators had already shot down the company’s main application for the drug twice — in September and April — because of deficiencies at the Iceland plant. The problems stemmed originally from a March 2022 inspection, but the FDA is now saying issues remain after a reinspection in March 2023, Alvotech said Wednesday.
The end of AbbVie’s lucrative monopoly for Humira is one of the biggest stories in the pharmaceutical world this year. For years, AbbVie collected new patents and erected legal hurdles to keep competition away from a drug that brought in more than $21 billion in revenue last year.
A series of legal settlements meant that Amgen got first crack at the market, introducing its biosimilar version of Humira earlier this year. Court settlements have cleared another wave of products to launch in the coming days, and Alvotech is among them. But without FDA approval, the company will stay on the sidelines.
Alvotech said it will resubmit its application for approval and the interchangeability designation. Importantly, the FDA didn’t cite any issues other than the manufacturing deficiencies in its latest rejection, meaning Alvotech may still win the coveted designation when it finally gets to market. That day is a ways off, though; a new application will trigger another six-month review period.
The latest FDA rejection may also have implications for other biosimilars under development at Alvotech. To bridge the gap in revenue and support the rest of its pipeline, Alvotech said it’s considering equity financing, a bond sale and debt financing. The company already has interest from its largest shareholder – ATP Holdings – in providing as much as $100 million.