The FDA has accepted Novartis’ submission for its biosimilar of Amgen’s Enbrel, which could mark the second time Amgen sees biosimilar competition from the Swiss company.
Novartis’ biologics arm Sandoz says it believes its two pivotal studies prove that its biosimilar is essentially the same as Enbrel (etanercept). It is seeking approval in all of the autoimmune disease drug’s indications.
“The acceptance of our regulatory submission by the FDA today is a significant step towards increasing patient access to these life-changing medicines," says Mark McCamish, head of global biopharmaceutical and oncology injectables development at Sandoz.
Merck and Samsung Bioepis have won approval for biosimilar etanercept in South Korea, while Samsung and Biogen are working on bringing a copy to Europe – but McCamish says that Sandoz “believes we are the first company to receive FDA file acceptance of a biosimilar version of etanercept”.
Enbrel, which is sold by Pfizer outside of the US, brought in sales of $9 billion last year, making it the world’s fifth-biggest selling medicine.
Earlier this year Sandoz launched the first biosimilar in the US – Zarxio, a copycat version of Amgen’s Neupogen (filgrastim). Amgen attempted to block the sale of the drug with a temporary injunction until an ongoing patent dispute between the firms is settled, but this was rejected by the US Court of Appeals for the Federal Circuit.
Zarxio is sold at a 15% discount to Neupogen in the US.