Eye on Pharma: Samsung Bioepis' Biosimilars Brought in $175 Million Last Quarter

The Center for Biosimilars Staff

During the first quarter of 2019, Samsung Bioepis’ biosimilars revenue increased to $175 million, up from $128 million in the first quarter of 2018. Those numbers, say Biogen, are driven by the launch of biosimilar adalimumab, Imraldi.

During the first quarter of 2019, Samsung Bioepis’ biosimilars revenue increased to $175 million, up from $128 million in the first quarter of 2018. Those numbers, say Biogen, are driven by the launch of biosimilar adalimumab, Imraldi.

Biogen, which together with its partner Samsung BioLogics forms Samsung Bioepis, reported its first quarter 2019 financial results on April 24.

The partnership has 3 biosimilars that are currently in the marketplace: a biosimilar etanercept (Benepali) referencing Enbrel; Imraldi, referencing Humira; and a biosimilar infliximab, sold as Flixabi in the European Union and as Renflexis in the United States, referencing Remicade.

Benepali sales were up 3% year over year, for a total of $124 million in revenue. Flixabi was up 123% year over year, for $15 million in revenue. Imraldi, which was launched in October 2018, was up 114% quarter over quarter, for $36 million in revenue.

These numbers come after reports that biosimilar adalimumab in general—and Imraldi in particular—are off to a strong start in Europe. IQVIA data released in the first quarter of the year show that in Germany, which had the most biosimilar adalimumab options available in November 2018, the greatest percentages of patients who switched from Humira to another option were transitioned to Imraldi (37%). Sandoz’s Hyrimoz and Amgen’s Amgevita trailed behind at 15% and 12%, respectively.

In the United Kingdom, which was responsible for the most consumption of brand-name Humira in the European Union as of September 2018, Imraldi was awarded 45% of the market via a centralized tender. Amgevita and Sandoz were each awarded roughly one-fourth of the market, and Mylan’s 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.”

Samsung Bioepis continues to develop other biosimilar agents; currently in the drug maker’s pipeline are FDA- and European Medicines Agency—approved trastuzumab biosimilar Ontruzant, a bevacizumab biosimilar undergoing a phase 3 study, a ranibizumab biosimilar undergoing a phase 3 study, and an eculizumab biosimilar currently in phase 1 clinical trials.