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Wire · regulatory

Second Proposed Interchangeable Vedolizumab aBLA from Alvotech and Teva Accepted by FDA

3 September 2026 · By · Wire by Fusion42

Published

3 September 2026

Topic

regulatory

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at jdsupra.com →

◆ Verified

Fusion42 · 3 September 2026 · Fusion42 review

The FDA has accepted a second proposed interchangeable biosimilar application (aBLA) for vedolizumab from Alvotech and Teva, marking a significant regulatory milestone in biosimilar competition for this biologic drug.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ ◆ The Wire takeaway

The FDA allowing a second interchangeable vedolizumab biosimilar sets new ground for you in biotech by accelerating substitution and broadening competition now. Prepare your commercial strategy to capitalize on pharmacist-driven switches soon.

◆ Coverage

1 source · 3 Sep 2026

◆ Related on Wire

◆ Topics

BiotechbiosimilarsFDA-approvalvedolizumabhealthcare-regulationalvotechteva