The EU Patent of the Best Selling Drug Has Expired, What Does it Mean for Biotech?

Humira EU patent expired biosimilars

AbbVie’s Humira, a treatment for inflammatory disease and the world’s best-selling drug, is no longer patent-protected in the EU. Competitors are already taking advantage of it.

Humira is an antibody drug, called adalimumab, that has been topping the lists of best-selling drugs for years. Last year alone, it made over €15B in sales worldwide.

The antibody was discovered by BASF and Cambridge Antibody Technology in the 90s using phage display, a technique that was awarded a Nobel prize this month. Commercialized by AbbVie, the drug’s success is due to the wide range of indications it is prescribed for. Humira is used to treat multiple inflammatory conditions, including rheumatoid arthritis, psoriasis, and Crohn’s disease.

The expiration of its EU patent opens the door for biosimilars (the generic equivalent of a biological drug), which will bring a significant price reduction. Simon Stevens, CEO of the UK’s NHS, has stated that thousands of patients in the UK receiving Humira will be switched to biosimilars, which is expected to save the NHS £150M a year. Humira is the drug that the NHS spends the most on every year, costing over £400M a year for the more than 46,000 patients that are prescribed the drug.

Three biosimilars of Humira launched immediately after the patent expired: Novartis’ Hyrimoz, Amgen’s Amgevita, and Biogen’s Imraldi. Mylan and Fujifilm’s Hulio and Boehringer Ingelheim’s Cyltezo could soon follow, as they have already received marketing authorization in the EU.

The patent expiry could also benefit biotechs developing treatments in combination with adalimumab, which will be able to offer their treatments at a lower price.

In India, biosimilars of Humira have been available since 2014 at a fifth of the US price. In the US, the patent expired in 2016. However, Amgen managed to extend the protection until 2023 thanks to over 100 patents covering different processes and techniques used to manufacture the drug. 

Images via Shutterstock

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