Fresenius Kabi Steps Up Its Biosimilar Game With Biosimilar Approval in Europe, Acquisitions

Fresenius Kabi accomplished 3 biosimilar targets recently, with the announcement of its pegfilgrastim biosimilar receiving the green light from the European Commission, its purchase of a majority stake in biosimilar manufacturer mAbxience, and its acquisition of Ivenix.

European Approval of Pegfilgrastim Biosimilar

The European Commission authorized Fresenius Kabi’s Stimufend, a biosimilar referencing Neulasta, for marketing across the European Union, making it the company’s first European approval for an oncology biosimilar and second European approval overall. Stimufend was approved for all of the same indications as the reference product.

Pegfilgrstim products are used in patients with nonmyeloid cancer who are undergoing myelosuppressive chemotherapy and are at risk of febrile neutropenia, a common chemotherapy-related complication characterized by a low level of certain white blood cells, which can be life-threatening.

“With the approval of this new biosimilar product in Europe, we are leveraging our heritage in oncology and expanding our oncology portfolio to better support the treatment experience and clinical outcomes for patients with cancer. We are proud to be ‘caring for life’ and to continue to deliver high-quality and affordable therapies for cancer and autoimmune diseases, while easing the burden on local healthcare systems,” said Michael Schönhofen, PhD, chief operating officer and board member at Fresenius Kabi, in a company statement.

The company said that it is expected to launch a prefilled syringe of the biosimilar in several European markets over the coming months. Fresenius Kabi has also filed for regulatory approval for Stimufend in the United States, where is currently under review by the FDA.

Two Big Acquisitions

Additionally, the Switzerland-based company announced that it bought a majority stake (55%) in mAbxience and fully acquired Ivenix, a specialized infusion therapy company.

Fresenius Kabi will give mAbxience €495 million in upfront and milestone payments. The purchase of Ivenix will cost Fresenius Kabi $240 million in similar payments that will be strictly linked to the achievement of commercial and operating targets.

The majority stake will provide Fesenius Kabi a strong partnership with growth potential in biosimilar markets. mAbxience currently has 2 commercialized biosimilars, a rituximab product and a bevacizumab product.

Through Fresenius Kabi’s in-house biosimilars programs and its investment in mAbxience, Fresenius Kabi said that it expects to capture an overproportionate share of the underlying rapid growth in the biopharmaceutical market. The deal is expected to close by mid-year 2022.

Ivenix was a privately held company based in North Andover, Massachusetts in the United States. The company has developed the an advanced infusion system, which features a large volume pump with administration sets, infusion management software tools, applications and analytics access to inform care and advance infusion efficiency. The Ivenix Infusion System was approved by the FDA and launched in late 2021. The transaction is expected to close by the middle of 2022.

“Through these acquisitions we are further strengthening and leveraging Fresenius Kabi's position, as both perfectly complement the company's growth businesses in biopharmaceuticals and medical technology….In this way, we are creating even better conditions for providing ever better medicine to ever more people. At the same time, we create meaningful value for our shareholders,” said Stephan Surm, CEO of Fresenius, Fresenius Kabi’s parent company, in another company statement.

Michael Sen, CEO of Fresenius Kabi, continued, “With the acquisition of Ivenix, we add the next generation infusion therapy platform; we complement and strengthen our existing infusion therapy offering and we create a superior portfolio for the US market. With mAbxience, we are making a step-change in our biopharmaceuticals profile. This is a highly complementary transaction in terms of biologics pipeline, manufacturing capabilities and the business model. mAbxience is two businesses in one company. mAbxience and Ivenix as portfolio advancements are good for patients, good for healthcare providers and our company.”