FDA clears second submission under Sandoz's Enzeevu biologics license application

The U.S. Food and Drug Administration approved a second submission filed under the original biologics license application for Enzeevu, an injectable product from Sandoz Inc. The record identifies this as submission number 2 under application number BLA761382, with an original submission type and an approved status as of October 22, 2026.¹

Enzeevu is formulated as an injection containing aflibercept-abzv. The product is listed with a strength of 2MG (0.05ML of 40MG/ML) and an injectable dosage form.¹

The FDA designated the review as standard priority rather than expedited. The submission carried a review priority of standard.¹

An approval letter tied to this submission was dated October 23, 2026, one day after the submission status date listed in the FDA database. The agency's application documents include a letter dated 20261023.¹

The distinction between this filing and the original BLA approval matters for tracking the product's regulatory history: this is not a separate original application but an additional submission processed under the same application number, reflecting a subsequent regulatory action rather than a second independent biologics license.

No further details on the nature of this submission, such as whether it involved a labeling change, manufacturing update, or other amendment, are included in the available record.