On 22 September 2017, a Delaware federal jury found that Hospira infringed the 5,856,298 (‘298) patent on Epogen, which covers the creation of specialized erythropoietin protein cells that stimulate the creation of red blood cells in anaemia patients. The jury rejected Hospira’s argument that it was protected by a safe harbour [35 U.S.C. § 271(e)(1)], which allows for use of patented processes for the purpose of gaining US Food and Drug Administration (FDA) approval. The jury found that 14 of Hospira’s 21 biosimilar batches were not covered by the safe harbour.

The jury did rule, however, that Hospira had not infringed a second Amgen patent covering a process for selecting and collecting different forms of erythropoietin protein cell molecules for better results.

The ruling is not the only bad news Hospira and parent company Pfizer have had lately when it comes to their epoetin alfa biosimilar. In June 2017, Pfizer received a second complete response letter (CRL) from FDA for the candidate biosimilar. While FDA’s first CRL, issued in 2015, asked for additional data, the latest CRL cited deficiencies at Hospira’s manufacturing site in McPherson, Kansas, USA. The letter listed significant good manufacturing practice (GMP) violations for finished pharmaceuticals at the facility, which was listed as the potential manufacturing site for the biosimilar [1]. The rejection of the drug came despite FDA advisors recommending approval of the biosimilar in June 2017 [2].

Hospira’s Retacrit (epoetin zeta) was approved in the European Union back in 2007 [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA rejects Pfizer’s epoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Pfizer-s-epoetin-alfa-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA advisors recommend approval of Pfizer’s epoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisors-recommend-approval-of-Pfizer-s-epoetin-alfa-biosimilar
3.    GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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