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US Upholds $70m Hospira Epogen Verdict

Biosimilar Safe Harbors Need Record Of Non-Commercial Use, 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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Hospira Will Not Be Reheard On Retacrit Biosimilar

Hospira has been frustrated again in long-running litigation concerning its Retacrit biosimilar to Amgen’s Epogen, in a case closely watched by the biopharma industry as it addressed what constitutes a safe harbor for a biosimilar applicant.

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”.

Hospira is hit for US$80mn

Pfizer’s Hospira will have to pay Amgen more than US$80 million in damages over an infringed US patent protecting Epogen (epoetin alfa). A final judgement issued by Delaware District Judge Richard Andrews awarded the originator pre-judgement interest of just over US$10.0 million on top of the US$70 million damages granted by a jury last year. In addition, Hospira will have to pay post-judgement interest calculated at the statutory rate of 1.31%.

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