AVT06 (aflibercept)

AVT06 Approval Pending

AVT06 (aflibercept)

AVT06 Approval Pending

U.S. License Holder:

Alvotech / Teva

Date of License:

aBLA accepted by FDA February-2025

Last Update:

Jan-08-2026

approved_indications FDA-Approved Indications

AVT06 (aflibercept) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Afiveg (STADA) (August-2025)
Mynzepli (Advanz Pharma / Alvotech) (August-2025)

Biosimilars Approved In Japan

AVT06 (Alvotech / Fuji Pharma) (September-2025)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

PGR2025-00085

U.S. Patent No.
12,168,036 (Methods for Treating Angiogenic Eye Disorders with High Doses of VEGF Receptor Fusion Proteins)

Patent Owner
Regeneron Pharmaceuticals, Inc.

Petitioner(s)
Alvotech USA Inc.; Alvotech hf.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-38

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Challenges Also Include Written Description (Claims 1-38); Awaiting Institution Decision

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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