AbbVie braces for impact of Humira biosimilars in Europe

AbbVie looks set to lose several billion dollars in revenue from Humira, as its soon to expire European patent presents healthcare providers with a major cost-saving opportunity for a biosimilar switch. 

Humira (adalimumab), which is used to treat a range of inflammatory diseases including rheumatoid arthritis, Crohn’s disease, ulcerative colitis and psoriasis will see its European patent expire in mid-October this year.

Healthcare providers across the European Union could then replace Humira with significantly cheaper biosimilar alternatives from Amgen, Sandoz, Samsung Bioepis and Boehringer Ingelheim.

The current annual cost of Humira in the UK is £9,295 per patient based on 26 injections per year.

Just in the last financial year the NHS was able to save £324 million by switching to biosimilars and generic medicines.

The NHS also announced its plans to make further savings of £200 million this year as “two further original biological medicines are due to come off patent”.

According to Reuters, NHS England “told administrators earlier this year not to sign any new contracts that extend beyond 16 October” when it comes to Humira. This is the date when Humira will lose its patent protection.

This move would suggest that the NHS learned from the previous long switch over period of Johnson & Johnson’s Remicade (infliximab) biosimilar, and will act faster with Humira.

According to Reuters, healthcare professionals in a few European countries are already able to freely use biosimilar drug versions when prescribing medication.

The German healthcare system leaves brand decisions to clinicians, who are free to decide which version of adalimumab they think is the best.

Scandinavian countries, which are the most liberal when it comes to the use of biosimilars, have already achieved price discounts of up to 70%.

Global Humira sales contributed 65% to the total of the pharma giant’s revenue, reaching $18.4 billion (£14.27 billion) in the last financial year. This includes the hefty sum of $6 billion from outside of the US, although the drug’s price is nearly doubled in the US compared to European countries.

But, Abbvie had a significant amount of time to prepare for the loss of European patent. The company CEO, Richard Gonzalez, said in July he would compete on price to “maintain the vast majority of the line”.

The firm also argues that patients who are stable on existing medication should not be switched to cheaper drugs for non-medical reasons such as price, but also admitted to direct negotiations with hospitals in several EU countries to maintain Humira use.

AbbVie’s executives, perhaps guided by previously slow biosimilar adoption in Europe, have forecast a drop of Humira sales in Europe of only around 18 to 20%, by the end of next year.

In the US AbbVie holds the patent for Humira until 2023 giving the company a few more years for contingency planning.

The US FDA is currently looking to encourage use of biosimilars and generics to cut costs, and is holding a public hearing on this next week.

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