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Fresenius Kabi Maps Out Biosimilar Strategy


The Germany-based company with global operations plans to ramp up its biosimilars portfolio through 2025.

Fresenius Kabi, a Bad Homburg, Germany-based biopharmaceutical company with global operations, mapped out an ambitious biosimilar launch program as it released earnings data that showed a 4% decline in net income ($2.2 billion) and 2% growth in sales ($44.0 billion) for 2020.

The company expressed confidence in its potential to make biosimilars an exceptional driver of income in the near future, although company executives described “unprecedented challenges” over the past year of the coronavirus disease 2019 (COVID-19) pandemic that affected performance.

“I am convinced these times will reward corporates who can draw resilience from their large critical infrastructure and well-proven business models,” said Stephan Sturm, CEO, in an investor presentation.

Fresenius has an adalimumab biosimilar that has been launched in 22 countries, most recently Canada. In the second quarter of 2021, the product will be launched in Australia; and in the third quarter, Brazil. A US launch is planned in 2023.

The company said its biologics license application for a pegfilgrastim biosimilar was accepted by the FDA and European Medicines Association in May 2020. In those markets, the product is intended to launch in a prefilled syringe in the third quarter of 2021. In 2022, Fresenius hopes to launch a pegfilgrastim on-body injector, a device that has enabled the originator company, Amgen, to capture significant market share (US market, 54%).

“Even though the prefilled syringe launch is important, the planned on-body device market entry is financially significantly more meaningful for us,” Sturm said.

The company has previously announced plans to bring a tocilizumab biosimilar to market, and the anticipated launch date is 2023 in the US and EU markets for subcutaneous and intravenous versions of this. The tocilizumab biosimilar would reference Actemra, for the treatment of rheumatoid arthritis. “The financially more meaningful market for us is the subcutaneous dosage form, since we are currently assuming to lead the competition here,” Sturm said.

Autoimmune biosimilars and an oncology biosimilar are slated for launch in 2024 and 2025, respectively, in the US and EU markets, although further description was not provided in the investor presentation.

Whereas biosimilars are an increasingly important part of Fresenius’ growth strategy, the company has a broad portfolio of therapeutic products in oncology, diabetes, critical care, liver and renal insufficiency, among others.

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