Novartis kicked off a new era in US medicine on Thursday with the launch of the first ‘biosimilar’ copy of a biotechnology drug approved in the United States, following a green light from a US appeals court.
Novartis unit Sandoz said Zarxio, its form of Amgen’s white blood cell-boosting product Neupogen, would increase access to an important treatment by offering a ‘high-quality, more affordable version’. US biotech group Amgen had tried to stop the sale of Zarxio, also known as filgrastim-sndz, but the Washington-based appeals court rejected its attempt to block the launch.
The potential for copycats to take business from original biotech drug brands is increasingly grabbing investors’ attention, although uncertainties remain as to how quickly so-called biosimilars will win business.
Biosimilars have been on the market in Europe since 2006.
However, the US regulatory pathway for biosimilars, which are made in living cells and can never be exact replicas of originals, was only established by a healthcare reform in 2010. The arrival of biosimilars threatens companies heavily reliant on biotech drugs, such as Amgen, AbbVie and Roche, and Citigroup analysts have predicted a transfer of at least $110 billion of value from innovator companies to copycat producers in the next decade.
Novartis did not immediately announce the price it would charge for Zarxio in the United States.
Neupogen is a $1.2 billion-a-year medicine for Amgen that boosts white blood cell counts to fight infections in cancer patients.
Insurers hope biosimilars will eventually cost the public 40 per cent to 50 per cent less than the original brands.