First wave of Humira biosimilars enters EU market

AbbVie’s Humira (adalimumab) is one of the best selling drugs of all time​ and now biosimilar manufacturers will be able to market their version of the drug in a majority of countries across the EU.

The originator biologic secured sales of $4.1bn (€3.54bn) in Europe for the 12 months ending December 31, 2017, according to IQVIA​.

As to how far the launch of biosimilars in Europe will cut into those sales remains unclear, but, in an emailed statement, Novartis has projected it could cut the bill associated by Humira in half.

Novartis’ subsidiary, Sandoz launches its Humira biosimilar Hyrimoz today and it stated that while the NHS spends £500m (€660m) per year on Humira, the use of its biosimilar could reduce this bill down to £250m.

Kavya Gopal, head of speciality business at Sandoz UK, said: “Now that doctors can prescribe Hyrimoz […] the NHS has the opportunity to increase patient access to biologic treatments. As we’ve worked to launch Hyrimoz as the Humira patent expires, the NHS can start saving money from today.”​

Amgen similarly announced that its biosimilar, Amgevita – the first Humira biosimilar given approval by the European Commission – has launched in a European-wide move.

A spokesperson for Amgen explained how the UK market, in particular, has been strong in adopting biosimilars, "The outlook for biosimilars in the UK is really favourable. NHS England has issued guidance to support the adoption and uptake of biosimilars​, and called for 90% of new patients to be prescribed the best value biological medicine within three months of a biosimilar launch, and 80% of existing patients to be transitioned within 12 months – so it is clear the appetite is there. At Amgen, we have believed for a long time that biosimilars have huge potential to unlock cost savings for the NHS in a way we haven’t seen before. What will be important is that clinicians are able to choose the right biosimilar for their needs and their patients’ needs."​

With today’s launch, Sandoz now has five biosimilars available on the market in Europe and Amgen has two.

US waits on Humira biosimilars​

While the number of biosimilar launches in Europe is growing and uptake is increasing, the same cannot be said for the US; a major factor in the Food and Drug Administration (FDA) launching its own biosimilar action plan​ to encourage innovation in the area.

AbbVie holds strong patent protection on Humira in the US, which has dissuaded some rival companies from broaching an ‘at risk’ launch.

This has led to a number of companies agreeing to deals with AbbVie for the launch of their biosimilars​, with the first wave expected in 2023 – a full five years after the EU gains access.