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Stada Gets FDA Nod For US Epoetin Alfa Supply

Adds US Market To Existing European Supply Deal With Pfizer For Epogen/Procrit Biosimilar

Executive Summary

Stada has received US FDA approval to supply the Retacrit epoetin alfa biosimilar to partner Pfizer for the US market, allowing it to expand on an existing European supply arrangement.

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Samsung Biologics has struck a deal worth over $400m to manufacture multiple biosimilars for Pfizer.

Pfizer’s Retacrit undercuts rivals

Pfizer has launched its Retacrit (epoetin alfa-epbx) biosimilar in the US – the first US biosimilar rival to the Procrit and Epogen epoetin alfa brands for treating anaemia – at a price that undercuts these versions by around three-fifths and more than a third respectively. Highlighting the “substantial discount” represented by Retacrit’s wholesale acquisition cost (WAC) of US$11.03 per 1,000 units/ml, Pfizer noted that this was 57.1% below US$25.72 for Procrit and 33.5% less than US$16.58 for Epogen. Pfizer has a US marketing tie-up with Vifor for Retacrit “in certain channels”.

Shortlist Revealed Ahead Of October Awards

Ahead of the Global Generics & Biosimilars Awards, which are this year being held on Wednesday 25 October at the Hotel Porta Fira in Barcelona, we reveal our final shortlist of entrants across all 14 categories.

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