USA — Alvotech and Teva Pharmaceuticals will not be able to launch their biosimilar version of AbbVie’s inflammatory disease drug Humira as scheduled in July.
The delay comes as the Food and Drug Administration (FDA) once again raised concerns about manufacturing issues at a plant in Iceland.
The FDA issued a complete response letter to Alvotech regarding its application to market its product, AVT02, as an “interchangeable” biosimilar to Humira.
This designation is highly sought after by biosimilar makers because it allows pharmacists to substitute the copycat version for the branded product without involving the original prescribing doctor.
Previously, regulators had rejected Alvotech’s main application for the drug twice, in September and April, due to deficiencies at the Iceland plant.
Although the problems initially arose from a March 2022 inspection, the FDA now states that issues persist after a reinspection in March 2023, as reported by Alvotech.
The expiration of AbbVie’s lucrative monopoly on Humira is one of the significant stories in the pharmaceutical industry this year.
AbbVie had obtained new patents and established legal barriers to prevent competition for years, as Humira generated over US$21 billion in revenue last year.
Amgen gained the opportunity to enter the market with its biosimilar version of Humira earlier this year due to a series of legal settlements.
Additional court settlements have paved the way for other products to launch soon, including Alvotech’s biosimilar. However, without FDA approval, Alvotech will remain on the sidelines.
Alvotech intends to resubmit its application for approval, including the request for interchangeability designation.
Encouragingly, the FDA’s latest rejection did not cite any issues beyond the manufacturing deficiencies, indicating that Alvotech still has a chance to secure the coveted designation once it finally reaches the market.
However, the actual launch is still a considerable distance away, as a new application will trigger another six-month review period.
The recent FDA rejection may also have implications for other biosimilars in development at Alvotech.
To bridge the revenue gap and support the rest of its pipeline, Alvotech is exploring options such as equity financing, a bond sale, and debt financing.
The company has already received interest from its largest shareholder, ATP Holdings, which is willing to provide up to US$100 million in funding.
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