Novartis subsidiary Sandoz filed for approval of a biologic product – a version of the anti-infective Neupogen - with the US Food and Drug Administration (FDA) last week, becoming the first drugmaker to publicly announce it was filing under the 351(k) biosimilar pathway.
Hospira describes itself as having one of the largest biosimilar pipelines in the industry and while reporting its Q2 2014 results this week reaffirmed it was on track to file a submission with the FDA for its biosimilar EPO (erythropoietin) later this year or early 2015.
“We expect to be among the first, if not the first, to launch biosimilar EPO in the US when the market forms,” CEO Michael Ball told investors.
The firm has previously announced it will submit its biosimilars through the FDA’s 351(k) pathway which requires significant preclinical and clinical data.
For the second quarter, the firm’s net profit more than doubled to $71m (€53m) compared to the same period last year, while revenue rose 11% to $1.1bn.
And Biopharma-Reporter will be delving deeper into the issues affecting biosimilars with a free virtual event on September 26. Join four industry experts as they discuss the development, manufacture and sale of such products in a 60 minute seminar hosted by our Editor-in-Chief Gareth Macdonald. Click here for more details...