StemCell Therapy

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab). The CRL noted that certain deficiencies, which were conveyed following the FDA’s reinspection of the company’s Reykjavik facility that concluded on March 17, 2023, must be satisfactorily resolved before the application can be approved.  No other deficiencies in the application were noted by the FDA.  Alvotech provided the FDA comprehensive responses to the inspection observations on April 3, 2023, and is awaiting communication from the agency assessing those responses.

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Alvotech Provides Regulatory Update on AVT02 Biologics License Application

This entry was posted on April 15, 2023 at 12:16 am and is filed under Eye Sight & Vision. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |