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Adalvo announces US dossier readiness of Semaglutide 1.34mg/ml pre-filled pen

15 March 2022

We are pleased to announce that our US dossier of Semaglutide 1.34mg/ml pre-filled pen is ready and available for licensing in Ex-US markets. We will now move full steam ahead to complete our EU dossier and prepare for an EU submission.

Our product is a generic and bioequivalent version of Ozempic and is indicated in the treatment of type II Diabetes. The brand sold $12.4bn globally in 2021 (according to IQVIA) and is a game-changing therapy in the treatment of this disease.

This product is being developed in close collaboration with one of our strategic partners and we are among the first companies who can offer a generic version on Ozempic globally.

By achieving this major milestone, we believe our Semaglutide development will become a true landmark, highlighting our ability to create a high-value portfolio, containing complex products, including peptide injections.

On top of this, Adalvo currently offers seven additional complex peptide projects with a combined global market size exceeding $20bn.