The Food and Drug Administration is set to decide by April 13, 2023, whether to approve Alvotech’s biosimilar to AbbVie’s top-selling drug Humira, pending a facility inspection the company said Thursday it is trying to schedule early next year.
Along with the news of the decision deadline, the Iceland-based drugmaker said the FDA had rejected its application to certify its biosimilar as an “interchangeable,” or substitutable by pharmacists for a Humira prescription. The FDA needed to decide this month on that separate interchangeability application.
The FDA has now turned down both Alovtech’s original application and its interchangeability submission because it needs to re-inspect the company’s Rekjavik factory following an initial inspection that found deficiencies. The condition for approval of both filings is passing the plant inspection, which Alvotech wants to schedule by the end of the first quarter of 2023.
Alvotech and AbbVie previously reached a settlement that will allow the launch of Alvotech’s copy on July 1, 2023. If the FDA approves both applications by then, Alvotech could have the first interchangeable biosimilar on the U.S. market that matches AbbVie’s best-selling formulation of Humira, a high-concentration mixture designed to be less painful.
Alvotech shares rose by more than 20% Thursday morning following the announcement.
Thursday’s news comes weeks after Alvotech shuffled its leadership team. CEO Mark Levick will step down effective Jan. 1, to be replaced by Robert Wessman, the company’s founder and executive chairman. The same day, Hafrun Fridriksdottir, previously executive vice president and head of global R&D at Teva, will become chief operating officer.
The first Humira biosimilar, Amgen’s Amjevita, is due to launch Jan. 31. Seven others have been approved, with launch dates either in July or later in 2023, per settlements with AbbVie. One, Boehringer Ingelheim’s Cytelzo, was cleared as an interchangeable in a low-concentration formulation. Pfizer has also applied for interchangeability for its low-concentration Abrilada.
Humira is the biggest test yet for biosimilars, the biologic equivalent of generic drugs. Congress opened the door to them in 2010, aiming to lower the high cost of branded biologic drugs that are typically used to treat cancer and chronic immune conditions.
Humira earned U.S. revenue of $13.6 billion over the first nine months of 2022, a 6.5% increase from the same period in 2021. But sales in the rest of the world have been in decline as biosimilars have already been launched in many countries, particularly in Europe.