Fresenius Kabi has launched Heparin Sodium injection in ready-to-administer non-DEHP freeflex® bags, expanding the company’s critical care portfolio. Fresenius Kabi offers a comprehensive portfolio of Heparin Sodium in the U.S. with multiple vial presentations, a pre-filled syringe and bag presentations.
Fresenius Kabi has signed a worldwide settlement and license agreement with AbbVie, settling all pending patent litigations between the two companies. Under the terms of the agreement and subject to marketing authorization by the health authorities, Fresenius Kabi’s biosimilar candidate of Humira®1 (adalimumab), MSB110222, could be commercialized in the United States from September 30, 2023.
On October 17, 2018 licenses under the agreement came into effect in certain countries in Europe in which AbbVie owns intellectual property. The application for marketing authorization for MSB11022 was submitted by Fresenius Kabi to the European Medicines Agency (EMA) at the end of last year. The dossier is currently under review. A first launch in Europe is expected in the first half of 2019.
1 Humira® (adalimumab) is a registered trademark of AbbVie Biotechnology Ltd.
2 MSB11022 is being developed as a biosimilar candidate of Humira® and is not yet approved by health authorities.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius Kabi has signed a worldwide settlement and license agreement with AbbVie, settling all pending patent litigations between the two companies. Under the terms of the agreement and subject to marketing authorization by the health authorities, Fresenius Kabi’s biosimilar candidate of Humira®* (adalimumab), MSB11022**, could be commercialized in the United States from September 30, 2023.
On October 17, 2018 licenses under the agreement came into effect in certain countries in Europe in which AbbVie owns intellectual property. The application for marketing authorization for MSB11022 was submitted by Fresenius Kabi to the European Medicines Agency (EMA) at the end of last year. The dossier is currently under review. A first launch in Europe is expected in the first half of 2019.
“This agreement is a major step on our way to successfully developing and commercializing our biosimilar portfolio," said Dr. Michael Schönhofen, Member of the Fresenius Kabi Management Board and President of the Pharmaceuticals Division. “In line with our caring for life philosophy, our aim is to contribute to broader access to affordable therapies for chronic and acute diseases. Biosimilar drugs are an increasingly important component in reaching this aim – to the benefit of patients and healthcare systems. The agreement with AbbVie provides further clarity regarding when we will be able to commercialize our biosimilar candidate of Humira®.”
*Humira® (adalimumab) is a registered trademark of AbbVie Biotechnology Ltd.
**MSB11022 is being developed as a biosimilar candidate of Humira® and is not yet approved by health authorities.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forwardlooking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forwardlooking statements in this release.
Fresenius Kabi has opened a new state-of-the-art compounding center in Canada. It involves an investment of 11 million Canadian dollars (more than €7 million), and the new site expands the company’s presence in Mississauga, Ontario. Fresenius Kabi is responding to increasing demand for large batches of compounded medications for patients in Canadian hospitals, and the 35,000-square-foot (3,300-square-meter) compounding center has the capacity to expand. The new facility is expected to employ 70 people by 2022.
Fresenius Kabi has opened a new state-of-the-art compounding center in Canada. It involves an investment of 11 million Canadian dollars (more than €7 million), and the new site expands the company’s presence in Mississauga, Ontario. Fresenius Kabi is responding to increasing demand for large batches of compounded medications for patients in Canadian hospitals, and the 35,000-square-foot (3,300-square-meter) compounding center has the capacity to expand. The new facility is expected to employ 70 people by 2022.
Fresenius Kabi has reached a milestone on the road to approval for another biosimilar. MSB11455, a biosimilar candidate for Neulasta® (pegfilgrastim), has met its primary endpoints in the two pivotal clinical studies. For more information please see the website of Fresenius Kabi.
Fresenius Kabi has reached a milestone on the road to approval for another biosimilar. MSB11455, a biosimilar candidate for Neulasta® (pegfilgrastim), has met its primary endpoints in the two pivotal clinical studies. For more information please see the website of Fresenius Kabi.
Atropine Sulfate Injection further expands the company's anesthesia and analgesia portfolio.
Glycopyrrolate Injection is the newest addition to the company’s anesthesia and analgesia portfolio.
Fresenius Kabi is expanding its production and warehouse capacity in Runcorn, England, to meet increasing demand in United Kingdom’s homecare market and from UK and Ireland hospitals. The expansion’s first stage will be a new distribution and operations center, scheduled to open in early 2019. A second services unit for producing aseptically compounded parenteral nutrition products will be completed by 2020. Fresenius Kabi will invest over €9 million in the expansion.