FDA slaps CRL on Alvotech Humira biosim

April 14, 2023

Iceland-based biotech Alvotech announced yesterday that the FDA had issued a complete response letter (CRL) for its BLA for AVT02, a Humira biosimilar.

According to the company’s recent statement, the CRL highlighted issues identified during the FDA's reinspection of Alvotech's Reykjavik facility on March 17, 2023, but no other concerns were flagged with the application. On April 3rd, Alvotech provided a comprehensive response to the inspection observations and is currently waiting for the FDA to evaluate and respond to its submission.

The company’s second BLA for AVT02 is currently being reviewed by the agency, which includes data that supports approval as a biosimilar and additional information that could potentially lead to an interchangeability designation. Pending a facility reinspection with a satisfactory outcome, the current Biosimilar User Fee Amendment (BsUFA) goal date for AVT02 is June 28, 2023. 

Alvotech was one of the last companies to ink a deal with AbbVie, agreeing to wait until July 2023 to launch its biosimilar. The companies had been in a lawsuit tug-o-war, with Alvotech accusing AbbVie of employing a “wrongful monopoly” on the drug and AbbVie later accusing Alvotech of recruiting one of its manufacturing execs to steal Humira trade secrets.

Earlier this year, Amgen’s Amjevita became the first Humira biosimilars available in the country. With competition scheduled to continue to enter the U.S. market in 2023, all eyes are on the adalimumab biosimilar charge, with many experts claiming that the future of biosimilars in the country will inevitably be shaped by the success or failure of these launches.