The drug – which is a biosimilar version of Amgen’s white blood cell booster – will be reviewed by the US regulator via the 351(k) abbreviated approval pathway established by the Biosimilar Price Competition and Innovation Act (BPCIA).
Originator biopharmaceuticals are filed under a full BLA, the 351(a) pathway, which requires that the applicant provide data proving the drug meets applicable standards without relying on previous FDA findings for any similar drug.
In contrast, biosimilar drugs filed through the 351(k) must be proven to be similar to the originator and can rely on data from that product.
Apotex’s filing is a “category 1 application” under the 351(k) pathway because it was submitted more than 10 years after the originator was licensed. This means the FDA has 10-months to complete its assessment, under the agency’s self-imposed performance goals.
Whether the FDA makes this deadline remains to be seen, but even if Grastofil is cleared it is unlikely to be the only Neupogen biosimilar to win agency approval this year.
Novartis’s subsidiary Sandoz filed its version of the drug EP2006 – marketed elsewhere as Zarzio – last July. While the review is not yet complete, last month the agency said the product is “highly similar” which was widely interpreted as a positive sign.
Days later the Oncologic Drugs Advisory Committee (ODAC) reviewing EP2006 recommended – after a panel discussion lasting just 17 minutes – it be approved for the same indications as Amgen’s originator.
If Sandoz’s product is approved it will be sold as Zarxio in the US.
Apotex filed a biosimilar version of Neulasta – a longer lasting white blood cell booster also made by Amgen – last December, also submitting the drug through the agency’s 351(k) pathway.
Like Grastofil, the Neulasta copycat was developed by Apotex in collaboration with India’s Intas Pharmaceuticals.