Daily Newsletter

13 October 2023

Daily Newsletter

13 October 2023

FDA rejects Alvotech’s BLA for Stelara biosimilar

Alvotech intends to resubmit the application for AVT04 shortly, triggering another six-month review cycle.

October 13 2023

The US Food and Drug Administration (FDA) has rejected Alvotech’s biologics licence application (BLA) for AVT04, a candidate that is a biosimilar to Johnson & Johnson’s (J&J) Stelara (ustekinumab).

In a complete response letter, the regulator pointed out deficiencies at Alvotech’s manufacturing facility in Reykjavik, Iceland, identified during a site inspection in March 2023.

No other deficiencies in the application were noted by the FDA, which stated that once these are resolved, it will approve the application.

Alvotech intends to resubmit the application for AVT04 to the FDA shortly.

This would trigger another six-month review cycle. A new Biosimilar User Fee Act goal date will be provided.

Alvotech chairman and CEO Robert Wessman stated: “AVT04 has recently been approved in Japan, and marketing applications for AVT04 are currently awaiting approval in other major markets.

“Based on our latest interactions with the FDA, we are currently expecting that the agency will reinspect our facility at the beginning of next year.

“We look forward to being able to bring AVT04 to US patients, pending a satisfactory inspection and BLA approval no later than in February 2025, in accordance with our licence entry date agreement.”

Alvotech and AVT04 commercialisation partner Teva Pharmaceuticals signed a settlement and licence agreement with J&J in June 2023.

AVT04 is expected to be available in the US in February 2025.

Alvotech also has commercial partners in Africa, China, Europe, Japan, the Middle East, South America and other Asian countries.

Significant opportunities and risks for disease-modifying therapies (DMTs) entering the PD market

As PD therapy currently centers on symptomatic treatment, the need for DMTs is one of the greatest unmet needs. Several companies within the late-stage PD pipeline are developing drugs that target PD via novel MOAs. KOLs remain hopeful that these companies will uncover a class of drugs that works effectively to slow or modify the disease course. Targeting α-synuclein and other neurotoxic proteins is a key strategy in the late-stage pipeline for DMTs.

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