Alvotech (ALVO.US), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech's second Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira (adalimumab). As the second of two BLAs submitted for AVT02, this BLA contained data to support approval as a high-concentration biosimilar and additional information to support the interchangeability designation.

The CRL noted that certain deficiencies, which were conveyed following the FDA's reinspection of the company's Reykjavik facility that concluded in March 2023, must be satisfactorily resolved before the application can be approved. No other deficiencies in the application were noted by the FDA.

Alvotech intends to resubmit a BLA for AVT02, including data supporting an interchangeability designation, to the FDA, which would trigger a six-month review period and a new Biosimilar User Fee Act (BsUFA) date.

Due to the expected delay in the potential approval of AVT02 in the US, as a result of the communication received from the FDA, Alvotech will explore options to raise additional capital, in order to continue advancing pipeline development in the near-term. In addition to AVT02, the company is currently developing a pipeline of 7 disclosed and 3 undisclosed biosimilar candidates. The financing options which will be explored include, but are not limited to, equity financing, sale of convertible bonds or other forms of debt financing. ATP Holdings ehf., a subsidiary of Aztiq, the largest shareholder of Alvotech, has today declared its interest in providing Alvotech with up to $100 million in proceeds from potential financing.

"We remain committed to bringing AVT02 to patients in the US, where the need for a high-concentration, interchangeable biosimilar to Humira remains significant," said Robert Wessman, Chairman and CEO of Alvotech. "We expect that a reinspection of our manufacturing facility will be required to gain approval in the US and anticipate a reinspection following resubmission of a BLA for AVT02."