Scott+Scott Attorneys at Law LLP (“Scott+Scott”), a shareholder and consumer rights litigation firm, is investigating whether Alvotech (the “Company”) (NASDAQ: ALVO) or certain of its officers and directors issued misleading and false statements and/or failed to disclose information material to investors in violation of federal securities laws.
Alvotech, through its subsidiaries, develops and manufactures biosimilar medicines for patients worldwide. It offers biosimilar products in the therapeutic areas of autoimmune, eye, and bone disorders, as well as cancer.
On November 2, 2025, Alvotech issued a press release stating that “the U.S. Food and Drug Administration (FDA) had issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Simponi® (golimumab).” According to the press release, “[t]he CRL noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility that concluded in July 2025, must be satisfactorily resolved before this BLA for AVT05 can be approved.”
Following this news, Alvotech’s stock price fell approximately 34%, to a closing price of $5.03 on November 3, 2025.
CONTACT:
Mandeep S. Minhas
Scott+Scott Attorneys at Law LLP
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