Alvotech’s Bold Bid: Second Attempt at FDA’s Seal of Approval for Humira Biosimilar Interchangeability

Alvotech’s Brave Bid for FDA Recognition: AVT02’s Quest for Biosimilar Glory

In a bold move, Alvotech has resubmitted its Biologics License Application to the FDA, gunning for that coveted interchangeability designation for AVT02, their high-concentration biosimilar of AbbVie’s Humira (adalimumab). The CEO, Robert Wessman, made the thrilling announcement during an investor call that left the biosimilar world abuzz.

While the exact action date remains shrouded in mystery, Wessman hinted at a compelling journey ahead as Alvotech works diligently to secure a “satisfactory inspection” for its manufacturing facility in Reykjavik, Iceland. If the stars align and approval is granted, AVT02 is poised to become a game-changer for the biotech company, with expectations of it making a significant impact on their business by 2024.

The path to FDA recognition has been no walk in the park for Alvotech. They’ve faced rejection twice already, first in April 2023 due to deficiencies at their Icelandic facility, and then in June when their bid for interchangeability was rebuffed. However, July brought a ray of hope when Alvotech expanded its partnership with Teva Pharmaceuticals, deepening collaboration in manufacturing and quality control at the Reykjavik plant.

The facility itself has had its share of struggles, earning an FDA warning letter in March 2022 that laid bare various quality control issues, including mold recoveries and bacterial contamination. Fast forward to a follow-up inspection a year later, and these problems had vanished.

CEO Wessman expressed confidence in the company’s investments in manufacturing and quality processes, believing they are now well-prepared for a satisfactory reinspection.

AVT02 won’t have an easy road if it secures FDA approval, as it faces stiff competition from at least eight Humira biosimilars, led by Amgen’s Amjevita. The biosimilar landscape has seen a flurry of activity, with new entrants like Yuflyma, Hadlima, Hyrimoz, and Cyltezo, each vying for their share of the market. Among these, only Cyltezo boasts the coveted interchangeability designation, allowing it to seamlessly replace the branded counterpart without a change in prescription.

In a financial twist to the tale, Alvotech reported robust results for the first half of 2023, with earnings soaring to $22.7 million, marking a substantial leap from the previous year’s $3.9 million in revenue. The plot thickens as Alvotech pushes forward in their quest for biosimilar success.

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