FDA approves new dosage form application for Formycon's biosimilar Ahzantive
The agency approved a second original application covering a new injectable dosage form of the aflibercept biosimilar Ahzantive.
The U.S. Food and Drug Administration approved an application for AHZANTIVE, a biosimilar referencing aflibercept, on October 22, 2026. The submission is listed as an original application, numbered as the second original submission for the product, and its approval letter is dated October 26, 2026.1
The application is classified under submission type Type 3, which the FDA designates for a new dosage form. The product is described as an injection in injectable dosage form, with the active ingredient listed as aflibercept-mrbb at a strength of 2mg per 0.05mL from a 40mg/mL concentration.1
The sponsor of record is Formycon AG, and the review was designated standard priority.1 The application carries the number BLA761378.
The FDA's drug approval database does not provide additional detail in this record on the intended indication, dosing schedule, or clinical data supporting the new dosage form submission. Readers seeking that information should consult the full approval letter or Formycon's own disclosures for further specifics on the product's labeling and intended use.
Fact check notes
- Imprecise
The agency approved a second original application covering a new injectable dosage form of the aflibercept biosimilar Ahzantive.
Approval and dosage-form classification are supported, but the source never calls Ahzantive a 'biosimilar' for aflibercept. - Imprecise
The U.S. Food and Drug Administration approved an application for AHZANTIVE, a biosimilar referencing aflibercept, on October 22, 2026.
Approval date matches submission_status_date, but 'biosimilar' label is not stated in the source. - Checker's noteThe entry repeatedly labels Ahzantive as a 'biosimilar' for aflibercept, a characterization not present in the source data.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Where the check questioned a sentence, its note is shown above. Not investment advice.