Alvotech is targeting a potentially significant fourth quarter of 2026, with U.S. regulatory decisions anticipated for three biosimilar programs following resubmissions to the FDA and the closure of a recent inspection of its manufacturing facility in Reykjavik.
Alvotech resubmitted Biologics License Applications for AVT05, its proposed biosimilar to Simponi and Simponi Aria, and AVT06, its proposed biosimilar to Eylea.
The company’s partner, Dr. Reddy’s Laboratories, separately resubmitted the U.S. application for AVT03, a proposed biosimilar to Prolia and Xgeva.
The FDA confirmed review completion goal dates consistent with its standard six-month review process, and Alvotech expects decisions on the three programs during the fourth quarter of 2026.
The regulatory progress follows extensive work on Alvotech’s manufacturing and quality systems.
The FDA recently closed a routine current good manufacturing practice surveillance inspection of the company’s Reykjavik manufacturing facility that was conducted during April and May. The inspection received a Voluntary Action Indicated classification.
Management described the resubmissions and inspection closure as an important inflection point for the company as it works toward the next wave of U.S. approvals.
Alvotech has also advanced other pipeline assets. The FDA accepted the Biologics License Application for AVT16, its proposed interchangeable biosimilar to Entyvio, while European regulators validated applications for AVT16 and AVT80.
The regulatory catalysts come after manufacturing-related constraints weighed heavily on Alvotech’s first-half financial performance.
Adjusted total revenue declined 30.8% to $211.9 million from $306.1 million. Product and service revenue dropped 48.3% to $105.9 million, while license and other revenue increased 4.4% to $105.7 million.
Adjusted EBITDA declined 12.7% to $46.9 million, while gross margin remained relatively stable at 54% compared with 55% a year earlier.
Alvotech said its manufacturing improvement program affected output and product availability during the first half. Manufacturing returned to planned operating levels by the end of the second quarter, and the company is rebuilding supply to meet confirmed customer demand.
Management said underlying commercial demand remains strong in both the U.S. and Europe, with five biosimilars now contributing to product revenue.
Alvotech has also strengthened its liquidity ahead of the expected regulatory decisions and potential product launches.
The company raised approximately $165 million in gross proceeds through an underwritten public offering and private placement and secured a new $75 million term loan facility from funds managed by GoldenTree Asset Management.
Alvotech maintained full-year 2026 guidance for revenue of $650 million to $700 million and adjusted EBITDA of $180 million to $220 million.
KEY QUOTE:
“This was an important inflection point as we work towards FDA approvals in the fourth quarter of 2026.”
Lisa Graver, CEO of Alvotech
