Fresenius Kabi announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company`s Biologics License Application (BLA) for MSB11455, a biosimilar candidate of Neulasta® (pegfilgrastim)*. This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline in the US. Fresenius Kabi also received acceptance for review of its regulatory submission for its pegfilgrastim biosimilar candidate from the European Medicines Agency this month. (* Neulasta® is a registered trademark of Amgen)
The European Medicines Agency (EMA) has accepted for review Fresenius Kabi`s Marketing Authorization Application (MAA) for MSB11455, a biosimilar candidate of Neulasta® (pegfilgrastim)*. This is another milestone for Fresenius Kabi following last year`s approval and launch of the company`s adalimumab biosimilar (Idacio®) in Europe. (* Neulasta® is a registered trademark of Amgen)
The European Medicines Agency (EMA) has accepted for review Fresenius Kabi`s Marketing Authorization Application (MAA) for MSB11455, a biosimilar candidate of Neulasta® (pegfilgrastim)*. This is another milestone for Fresenius Kabi following last year`s approval and launch of the company`s adalimumab biosimilar (Idacio®) in Europe. (* Neulasta® is a registered trademark of Amgen)
Micafungin for injection, an antifungal medicine, expands the company's anti-infective portfolio.
Potassium Phosphates Injection is now available in the United States in three FDA-approved presentations. Fresenius Kabi offers the broadest portfolio of Potassium Phosphates Injection in the United States.
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Industrial production of infusion solutions at Fresenius Kabi's plant in Friedberg, Germany. Download Image (JPG 1.63 MB) -
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A nurse prepares an intravenously administered (I.V.) drug. Fresenius Kabi is a leading supplier of I.V. generic drugs. More press photos can be found in our media center. Download Image (V 1.95 MB) -
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Filling of glass bottles with liquid pharmaceuticals at the Fresenius Kabi plant in Melrose Park, USA. More press photos can be found in our media center. Download Image (JPG 271 KB)
- Production of critical drugs scaled up with priority supply for COVID 19 patients
- Commitment to price stability for essential drugs for COVID-19 patients during pandemic
Fresenius Kabi is responding to the significant increase in worldwide demand for essential drugs for the treatment of COVID-19 patients, especially medicines used for sedation such as Propofol and pain management drugs. The company is maximizing supply with all compatible manufacturing capacity now dedicated to these vital drugs. Fresenius Kabi has made significant, future-oriented investments in recent years into both automation and capacity in its manufacturing facilities; these are now enabling treatment for more patients worldwide.
Fresenius Kabi will continue to align its manufacturing capacities to the dynamically developing demand resulting from the COVID-19 pandemic.
Fresenius Kabi is dedicated to protecting its workforce in all aspects and has introduced increased safety measures for employees across the organization. These safeguards will also facilitate continued operations at its production sites. To ensure uninterrupted access to the company’s medicines, devices and technologies Fresenius Kabi is working closely with governments and public health authorities around the world.
Stephan Sturm, CEO of Fresenius, said: “The COVID-19 pandemic poses particular challenges for our society. As a healthcare company whose mission is to offer better and affordable medicine to ever more people, we have a special responsibility that we will live up to also during these testing times. Irrespective of demand beyond our ability to supply, we commit ourselves to keeping prices for essential drugs for COVID-19 patients stable during this pandemic. My special thanks go to our employees around the world. I am very grateful for their extraordinary commitment.”
Mats Henriksson, CEO of Fresenius Kabi, said: “Our purpose is to put lifesaving medicines and technologies in the hands of healthcare professionals and to find answers to the challenges they face. This purpose has never been more important than today. We do whatever is possible to further increase manufacturing output and the supply of urgently needed products. I am inspired by the dedication of our employees who are committed to maintaining the supply of our medicines to patients and their families.”
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.
- Production of critical drugs scaled up with priority supply for COVID 19 patients
- Commitment to price stability for essential drugs for COVID-19 patients during pandemic
Fresenius Kabi is responding to the significant increase in worldwide demand for essential drugs for the treatment of COVID-19 patients, especially medicines used for sedation such as Propofol and pain management drugs. The company is maximizing supply with all compatible manufacturing capacity now dedicated to these vital drugs. Fresenius Kabi has made significant, future-oriented investments in recent years into both automation and capacity in its manufacturing facilities; these are now enabling treatment for more patients worldwide.
Fresenius Kabi will continue to align its manufacturing capacities to the dynamically developing demand resulting from the COVID-19 pandemic.
Fresenius Kabi is dedicated to protecting its workforce in all aspects and has introduced increased safety measures for employees across the organization. These safeguards will also facilitate continued operations at its production sites. To ensure uninterrupted access to the company’s medicines, devices and technologies Fresenius Kabi is working closely with governments and public health authorities around the world.
Stephan Sturm, CEO of Fresenius, said: “The COVID-19 pandemic poses particular challenges for our society. As a healthcare company whose mission is to offer better and affordable medicine to ever more people, we have a special responsibility that we will live up to also during these testing times. Irrespective of demand beyond our ability to supply, we commit ourselves to keeping prices for essential drugs for COVID-19 patients stable during this pandemic. My special thanks go to our employees around the world. I am very grateful for their extraordinary commitment.”
Mats Henriksson, CEO of Fresenius Kabi, said: “Our purpose is to put lifesaving medicines and technologies in the hands of healthcare professionals and to find answers to the challenges they face. This purpose has never been more important than today. We do whatever is possible to further increase manufacturing output and the supply of urgently needed products. I am inspired by the dedication of our employees who are committed to maintaining the supply of our medicines to patients and their families.”
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.
With virtually all of Fresenius Kabi’s manufacturing staff in China returning to work post government-imposed COVID-19 quarantine restrictions, the company is ramping-up production back to normal levels. With a further stabilization of the situation, Fresenius Kabi also expects a gradual resumption of its sales force activities in China. Even though Fresenius Kabi faced challenges due to the COVID-19 pandemic and the quarantine measures, there was no major interruption of production. Thus, the company can supply the Chinese population with essential pharmaceuticals and medical devices.
With virtually all of Fresenius Kabi’s manufacturing staff in China returning to work post government-imposed COVID-19 quarantine restrictions, the company is ramping-up production back to normal levels. With a further stabilization of the situation, Fresenius Kabi also expects a gradual resumption of its sales force activities in China. Even though Fresenius Kabi faced challenges due to the COVID-19 pandemic and the quarantine measures, there was no major interruption of production. Thus, the company can supply the Chinese population with essential pharmaceuticals and medical devices.
Sodium Chloride 3% is the newest addition to the company’s IV solution portfolio.