FDA approves first biosimilar

Novartis has become the first company to gain US approval for a biosimilar after the FDA said yes to its version of Amgen's Neupogen (filgrastim). 

The drug, which will be called Zarxio, is based on Amgen's treatment that was originally approved in 1991.

Like its originator drug, Zarxio has five licences all aimed at helping shore up white blood cell counts and is commonly used to ease the side effects of chemotherapy across a number of different cancers. 

Amgen makes around $1.4bn a year on the product, but Novartis should be able to gain a sizeable share of this market, as it will likely sell the drug at around 20-30% cheaper.

Zarxio also marks the arrival of biosimilars on the US market. Biosimilars have been in Europe for ten years, but the US market has long resisted the introduction of these medicines. 

In 2010 US President Barack Obama introduced new healthcare reforms that allowed biosimilars onto the market, but it has proved a difficult path for the regulator, which had no reference points for allowing a biosimilar to be approved.

This difficulty is still apparent as the FDA is calling Zarxio 'filgrastim-sndz' as Neupogen's official non-proprietary name. This is because there is still uncertainty over whether biosimilars in the country should have branded monikers. 

The main reason for allowing these types of drugs on the market, which are direct copies of the originator drug but require some research as they copy living cells, is down to cost savings.

Express Scripts estimates that the US healthcare system could save roughly ​$250bn over the next decade because of the introduction of biosimilars.

Meanwhile, global sales of copycat biologics are projected reach $35bn by 2020 and Sandoz, which has more than 50% share of the world biosimilars market, is set to have a major share of this.

It is already working on biosimilars of the blockbusters Humira, Enbrel, Rituxan and Procrit, all of which are currently worth $20bn collectively.