Early EU Experience Shows Positive Results for Samsung Bioepis' Biosimilar Adalimumab

The launch of biosimilar adalimumab products in the European Union in October 2018 was an important moment for health systems in serious need of cost savings on one of their top drugs for spending: Humira. Now, early data reported by IQVIA show that adalimumab biosimilars are off to a strong start in the EU market.

According to IQVIA’s data, 14 countries had biosimilar adalimumab available as of November 2018: the United Kingdom, Germany, France, Spain, Italy, the Netherlands, Belgium, Sweden, Ireland, Austria, Finland, Denmark, the Czech Republic, and Slovenia. Among these nations, Germany had the most biosimilar options available, with launches of Samsung Bioepis’ Imraldi, Amgen’s Amgevita, Sandoz’s Hyrimoz, and Mylan’s Hulio. Austria and Finland, by contrast, each had just 1 biosimilar available: Amgevita.

In Germany, the number of patients taking the brand-name Humira fell in November versus the year before biosimilars launched. While some patients were switched to other agents, such as the interleukin inhibitors sekukinumab (Cosentyx) or ustekinumab (Stelara) that are often used as alternatives for patients who lose response to anti—tumor necrosis factor therapies, the greatest percentages of patients who switched away from Humira were transitioned to Imraldi (37%), Hyrimoz (15%), and Amgevita (12%).

In the United Kingdom, which was responsible for the most consumption of brand-name Humira in the European Union as of September 2018, a centralized tender broke the adalimumab market into 11 regions, and awarded shares of the market to multiple bidders. Imraldi took the greatest share, with nearly 45% of the English market. Amgevita and Sandoz were each awarded roughly one-fourth of the market, and Hulio was awarded approximately 5% of the market.

According to IQVIA, “It is Samsung with Imraldi that has won out so far in the 2 markets that matter the most: Samsung has the largest potential market in the United Kingdom and has shown the most success in acquiring Humira patients in Germany.”