Alvotech receives FDA capacity approval as Alvotech stock gains 12.81 percent

Alvotech (LU2458332611) was trading at EUR 5.46 at Lang & Schwarz on October 5, 2026 at 8:52 p.m. CEST, up 12.81 percent versus the prior close of EUR 4.84. On October 5, FinanzNachrichten reported that the FDA approved a supplement allowing Alvotech to manufacture SIMLANDI drug substance in a second Reykjavik production suite.

FDA approval doubles U.S. capacity

The newly authorized DSM2 suite can be used alongside DSM1 for U.S. commercial supply of AVT02, the biosimilar marketed as SIMLANDI. The approval therefore doubles the drug substance manufacturing capacity available for the U.S. market, according to FinanzNachrichten.

The manufacturing decision follows the FDA's July 2026 closure of its latest inspection at the Reykjavik facility with a Voluntary Action Indicated classification. Alvotech said the agency may now act on other pending applications according to their individual goal dates, but each remains subject to separate regulatory review.

Revenue exceeded quarterly consensus

Alvotech's commercial and development pipeline remains central to the valuation case. In the quarter reported on August 20, 2026, revenue reached USD 106.00 million versus analyst consensus of USD 103.00 million, while earnings per share came in at minus USD 0.11 against consensus of minus USD 0.05, according to MarketBeat.

That combination puts the October 5 approval in a more specific context. The regulatory milestone improves manufacturing flexibility for an already marketed biosimilar, while the earnings comparison shows that revenue exceeded expectations even as per-share earnings missed consensus by USD 0.06.

Stock remains below its yearly high

Alvotech's Nasdaq-listed ALVO shares were at USD 6.12 on October 5, 2026 at 2:55 p.m. ET, according to the primary-exchange quote, versus a 52-week range of USD 2.94 to USD 9.05. The company had a market capitalization of USD 2.1 billion on that date.

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