Pfizer’s Retacrit Finally Clears US FDA, But Biosimilar’s Launch Date Is Still Unclear
First biosimilar of Epogen/Procrit might launch this year, but timing of market entry will depend on many factors, including ongoing patent litigation with Amgen in Delaware federal court.
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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.
Pfizer's suit claims J&J coerced payers by vowing to withhold all Remicade rebates if any of Pfizer's biosimilar Inflectra is reimbursed, but J&J says Pfizer has failed to show the value of Inflectra.
US FDA hands Pfizer its second complete response letter for its proposed biosimilar to Epogen/Procrit, citing manufacturing compliance concerns at a legacy Hospira manufacturing facility in Kansas that was the target of a February warning letter. Issue “is not directly related to EPO itself,” Pfizer’s Salomon Azoulay says.