The Food and Drug Administration has rejected an application from Alvotech for approval of the Iceland-based drugmaker’s copycat version of AbbVie’s top-selling Humira.
In a statement Monday, Alvotech said the FDA had informed it that deficiencies in the company’s manufacturing plant in Reykjavik need to be corrected before it can launch the drug in the U.S.
The regulator’s complete response letter follows a factory inspection that took place in March. Alvotech didn’t detail the deficiencies the FDA identified, but said it expects to fix them in time to launch its biosimilar drug as planned on July 1, 2023. The company added it also plans to resolve the issues before a December deadline the FDA has set on approval of the biosimilar, at which time the regulators will also decide whether to designate it as an “interchangeable” copy that can be substituted for Humira by pharmacists.
Alvotech shares fell 8% in morning trading Tuesday on the news. The drug, called AVT02, has been approved by regulators in Canada, the European Union, and several non-EU European countries, and is being reviewed in several others outside the U.S.
Alvotech had initially submitted AVT02 for U.S. approval in the fall of 2020. But a year later the FDA deferred any decision on its application due to difficulties in inspecting the company’s manufacturing process. Earlier this year, Alvotech submitted and the FDA accepted another application for AVT02 seeking interchangeable status. That application carries the December decision date from the FDA.
Alvotech’s biosimilar is one of as many as 12 Humira copies — seven of which have already been approved in the U.S. — that are targeting Humira’s $17 billion in annual U.S. sales. The main patent protecting Humira expired in 2016, but others granted by the U.S. government have kept biosimilar rivals at bay.
Legal settlements between AbbVie and biosimilar makers will allow one, Amgen’s Amjevita, to enter the U.S. market in January 2023, but many, including Alvotech’s, will be kept off the market until July 2023. Biosimilar rivals are likely to set a price below Humira’s annual list cost of nearly $80,000, potentially cutting into AbbVie’s sales and bringing down overall spending on the drug.
Under a commercialization deal with Alvotech, generic drugmaker Teva will sell AVT02 in the U.S.
Pharmaceutical executives will be closely watching the U.S. launch of Humira biosimilars as they try to assess how sales of branded biologics will fall as more of the biologic copies reach market. Johnson & Johnson’s Stelara, Regeneron’s Eylea and Merck & Co.’s Keytruda, all big sellers, are expected to face biosimilar competition in the coming years.