Biosimilar Safe Harbors Need Record Of Non-Commercial Use, Epogen Ruling Suggests
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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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”.
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.
Novartis co-leads industry forum on preapproval access that aims to share best practices and engage patient groups; Janssen is launching three pilots to leverage collection of preapproval access data.