Hospira seeks FDA nod for Epogen/Procrit biosimilar
This article was originally published in Scrip
On 12 January, Hospira became the fourth company in the US to disclose it had submitted a so-called 351(k) biosimilar biological product application to the FDA – following other firms Sandoz, Celltrion and Apotex.
The news, however, didn't impress Hospira investors. The firm's stock closed down 9 cents at $61.55 on 12 January, although the shares earlier gained 42 cents.
Hospira is seeking approval from the FDA to market Retacrit, an epoetin alfa biosimilar version of Amgen's Epogen and Johnson & Johnson's Procrit.
Hospira acknowledged it actually had submitted the 351(k) application on 16 December 2014, but waited nearly a month before revealing the action.
The company boasts it has one of the largest biosimilar pipeline in the industry and currently is the only US-based drug maker with biosimilars in Europe, where Hospira has marketed Retacrit since early 2008.
Hospira also markets a biosimilar version of Amgen's Neupogen (filgrastim) in Europe and Australia.
In 2013, Hospira became the first company in Europe to market a biosimilar monoclonal antibody – a version of J&J's Remicade (infliximab). Hospira sells the drug under the brand-name Inflectra in Europe.
Celltrion is hoping the FDA will approve the firm's infliximab biosimilar in the US, which the company wants to market as Remsima (scripintelligence.com, 11 August 2014).
Also in the US, Sandoz is pursuing a filgrastim biosimilar – making history earlier this month as the first company to have a 351(k) application go before an FDA advisory committee, where the product was warming embraced by the agency's panel of outside experts, as well as regulators (scripintelligence.com, 08 January 2015, 08 January 2015, 5 January 2015).
The firm also was the first to reveal its biosimilar application had been accepted by the FDA (scripintelligence.com, 24 July 2014).
Apotex also has an application for a biosimilar under FDA review – seeking to market a version of Amgen's Neulasta (pegfilgrastim) (scripintelligence.com, 18 December 2014).