Alvotech Seizes a Triumphant Third Shot: FDA Greenlights BLA for Game-Changing Humira Biosimilar

In a thrilling twist, the FDA has accepted Alvotech’s latest Biologics License Application (BLA) for AVT02, a high-concentration and interchangeable biosimilar aiming to dethrone AbbVie’s Humira (adalimumab).

This announcement follows a dramatic setback in June 2023 when the FDA rejected AVT02’s quest for interchangeability, delivering a stinging Complete Response Letter (CRL). The letter cited “certain deficiencies” within Alvotech’s Reykjavik, Iceland facility, demanding their resolution before any future applications would be entertained. A déjà vu moment occurred in April 2023 when the FDA issued another CRL, again pinpointing similar facility-related shortcomings.

In a bold comeback, Alvotech returned to the ring with a resubmission in September 2023, armed with additional Chemistry, Manufacturing, and Controls data. This time, the FDA is cautiously considering this submission as a “complete response” to previous concerns. All eyes are now on the FDA’s verdict, scheduled for February 24, 2024.

Alvotech’s CEO, Robert Wessman, expressed optimism, stating, “No deficiencies in our BLA have been noted by the FDA other than those associated with our facility. We now await further guidance from the FDA on the timing of a reinspection, which we expect to occur in advance of the BsUFA date.”

AVT02, in the U.S., stands as a potent monoclonal antibody vying for biosimilarity with Humira. It wields a similar mechanism of action, locking horns with tumor necrosis factor-alpha and thwarting its interaction with cell surface receptors. This dynamic combat against inflammation holds immense promise in the treatment of conditions like rheumatoid arthritis and Crohn’s disease.

While AVT02 has garnered approvals in numerous international markets, including the entire European Union, Canada, Saudi Arabia, Australia, and the U.K., its journey to U.S. approval has been a rollercoaster ride, marred by manufacturing challenges. In March 2022, Alvotech’s Reykjavik facility received a stern FDA warning letter, exposing quality control lapses and an alarming presence of mold in drug manufacturing areas.

Bacterial contamination also loomed ominously, surpassing acceptable levels, with the FDA deeming Alvotech’s corrective efforts “inadequate.” However, in a surprise turn of events, a follow-up inspection in March 2023 revealed no traces of these issues, hinting at Alvotech’s resolve to overcome adversity.

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