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Biosimilar Safe Harbors Need Record Of Non-Commercial Use, Epogen Ruling Suggests

Executive Summary

Federal Circuit affirms jury's $70m award to Amgen and finding that some Hospira biosimilar batches were not protected by the safe harbor. Decision conveys how biosimilar makers can obtain this protection from infringement suits.

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Biogen And Millennium May Be Ensnared In Tentacles Of Genentech’s Expired Cabilly Patent

Genentech claims Biogen and Millennium owe royalties on sales of Tysabri and Entyvio that were stockpiled when the Cabilly patent expired. Hospira faced similar litigation over its erythropoietin biosimilar and had to pay Amgen $70m in damages.

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”.

Epogen Biosimilar Jury Verdict May Ignite New 'Safe Harbor' Battle

Amgen awarded $70m in damages after jury finds certain batches of Hospira's Epogen biosimilar infringed a manufacturing process patent; case offers 'juicy legal issue' for Federal Circuit to address.


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