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FDA approves first radioligand equivalent, Curium's copycat of Novartis' Lutathera

Published

15 September 2026

Topic

opportunities

Sectors

Biotech

Geography

United States

Source

Read at fiercepharma.com

Verified

Fusion42 · 16 September 2026 · Fusion42 review

The FDA approved Curium's Bexlutry, the first generic equivalent radioligand therapy referencing Novartis’ Lutathera for gastroenteropancreatic neuroendocrine tumors, marking a significant move towards radioligand therapy generics in the US.

This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it.

◆ The Wire takeaway

You face a new competitor in radioligand therapies as Curium’s FDA approval clears a path for generics that challenge Novartis’ hold. Now is the time to reassess your supply chain and patient access strategies to stay competitive.

Coverage

2 sources · 15 Sep 2026

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Topics

Biotechfda-approvalradioligand-therapygeneric-drugscuriumnovartispharma