Sandoz sets out Neulasta biosim plan after Ph III data brings US approval a step closer
The news came days after the firm presented positive data from a trial comparing the drug with the Amgen original at the American Society of Haematology (ASH) annual meeting in Florida.
The results showed that the Sandoz drug – which was accepted for review by the US Food and Drug Administration (FDA) last month – was as effective at helping breast cancer patients maintain white blood cell levels as the Amgen reference drug.
A spokeswoman for the firm told us “if approved, our biosimilar pegfilgrastim will be produced within Novartis’ biomanufacturing network which includes facilities in Slovenia, Singapore, France and Austria.
Sandoz has signalled its intention to seek approval for its pegfilgrastim candidate for the same indications as Neulasta.
Biosimilar business
The Novartis became the only firm to be selling a biosimilar product in the US when it launched Zarxio in September.
Sandoz’s pegfilgrastim is the third biosimilar it has had accepted by the FDA for review. In October the agency said it would review its version of Amgen’s tumour necrosis factor inhibitor Enbrel (etanercept).
The firm has said it plans to file 10 biosimilar products in the US over the next three years.
The Sandoz Enbrel biosimilar is also being assessed by the European Medicines Agency (EMA), which accepted it for review this week.
The EMA decision comes a week after the regulator’s Committee for Medicinal Products for Human Use (CHMP) recommended that Benepali, a rival Enbrel biosimilar made by Samsung Bioepis, by approved.
