FDA to assess Neupogen biosimilar
pharmafile | February 3, 2010 | News story | Research and Development, Sales and Marketing | Hospira, Teva, biosimilars
US regulator the FDA has agreed to assess Teva’s application for a biosimilar version of Amgen’s Neupogen (filgrastim).
XM02, a granulocyte colony-stimulating factor (G-CSF), is designed to treat severe neutropenia, a hematological disorder characterised by an abnormally low number of white blood cells.
If approved the drug would be marketed under the name Neutroval by US pharma company Hospira, which last year acquired worldwide rights to the new version in a deal that also saw it gain manufacturing capacity for filgrastim and pegfilgrastim – a long-acting version of the drug marketed by Amgen as Neulasta.
The worldwide market for Neulasta and Neupogen currently stands at more than $2 billion.
Biosimilars – also called follow-on biologics – are, as far as possible, copies of original brands, although it is virtually impossible to show true bioequivalence.
They first appeared in Europe four years ago and now cover a range of protein-based drugs which are typically discounted 20% to 30% compared with the brand they copy.
The European Union gave XM02 marketing authorization in September 2008, and it has been launched in several EU markets under the brand name TevaGrastim.
A year ago Teva, the world’s largest generics manufacturer, established a joint venture with Lonza, one of the largest contract manufacturers of biologics, to exploit the biosimilars market.
Teva had already bought CoGenesys in a $400 million deal, and the companies are unlikely to be the only ones eyeing biosimilars as a major growth driver.
It is a potentially fertile time for such ventures. Although the lack of a regulatory route to market has been a huge stumbling block for biosimilars in the US, there are now proposals for an approval process in Barack Obama’s ongoing healthcare reforms.
Both House and Senate bills currently on the table advocate a 12-year period of market exclusivity.
As with so much of the controversial reforms, a fierce lobbying battle has ensued on this, with US industry group PhRMA wanting patent protection of at least 14 years on biologicals in return for easier biosimilar approvals.
However, the Federal Trade Commission said biologics needed no such guarantee because patent protection plus the difficulty of producing biosimilars would provide sufficient exclusivity.
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