Amid the confusion of the pandemic, fundamental business strategies are reshaping the biosimilar playing field, according to corporate earnings reports.
Facing pending competition from Amgen’s eculizumab biosimilar in 2025, which challenges Alexion’s eculizumab (Soliris) product, Alexion said it has managed to convert 70% of Soliris patients to its ravulizumab follow-on (Ultomiris), which received FDA approval in 2018, also for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
Soliris, an aging drug power hitter for Alexion, had net sales of $975.5 million in the second quarter, versus $980.8 million a year earlier. Ultomiris brought in $251.1 million in net sales for the quarter just ended, versus $54.2 million in the second quarter of 2019, a 363% increase, the company said.
“As anticipated, we have seen accelerated conversion from Soliris to Ultomiris,” the company said.
Alexion also noted that in the second quarter it received European Union approval for Ultomiris in atypical hemolytic uremic syndrome and announced positive phase 3 results for a weekly formulation of subcutaneous ravulizumab.
Alexion said it has phase 2/3 studies planned or underway for Soliris in neuromyelitis optica spectrum disorder and generalized myasthenia gravis. In addition, Japan’s ministry of health has granted Soliris an indication for Guillain-Barre syndrome.
Other Quarterly News
The second quarter of 2020 began and ended amid the coronavirus disease 2019 (COVID-19) pandemic, challenging biosimilar companies in new ways to achieve greater market share.
For Biogen, which partners on sales of biosimilars with Samsung Bioepis, during the 3 months ended June 30, 2020, sales of 3 biosimilar products—etanercept (Benepali), infliximab (Flixabi) and adalimumab (Imraldi)—dropped 7% to $171.6 million from $184.4 million in the same quarter a year ago.
Benepali’s sales totaled $106.2 million at end of the second quarter this year, down 12%; Imraldi’s, $44.8 million, down 5%; and Flixabi’s, $20.6 million. Sales of Flixabi rose 23%, from $16.8 million in the same quarter a year ago.
The company did not discuss reasons why the biosimilars performed worse than last year.
Frensenius, parent company of Fresenius Kabi, which has adalimumab, tocilizumab, and pegfilgrastim biosimilars in the pipeline, saw growth in sales of 2% but a decline in net income ($482 million) of 13% for the quarter just ended, compared with the same quarter in 2019.
For the first half of 2020, net income was down 6%, at $1.03 billion.
In May, Frensenius Kabi signed an agreement with Germany-based company medac, to market its adalimumab biosimilar Idacio in Germany. Medac provides methotrexate for the treatment of chronic inflammatory diseases and is often used in conjunction with adalimumab products.