Fresenius Kabi introduced Pralatrexate Injection, a drug for the treatment of relapsed or refractory peripheral T-cell lymphoma in the U.S. Fresenius Kabi Pralatrexate Injection is a generic of Folotyn® and is available to customers immediately. It is the newest addition to the company’s injectable oncology medicine portfolio, the largest in U.S. health care.
*Folotyn® is a registered trademark of Acrotech Biopharma.
Fresenius Kabi announced today it has launched Gadoterate Meglumine Injection, USP, a bioequivalent and therapeutic equivalent substitute for the contrast agent Dotarem®*. This is the second contrast agent introduced by Fresenius Kabi in the U.S. this year.
Contrast agents are used by radiologists to enhance the visibility of internal structures in imaging procedures such as MRI or CT scans. Contrast agents are a new category of health care products for Fresenius Kabi.
*Dotarem® is a registered trademark of Guerbet.
The U.S. Food and Drug Administration (FDA) has approved Fresenius Kabi’s pegfilgrastim biosimilar, Stimufend®, for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
The company expects to launch the product in a prefilled syringe next year and additionally in an on-body injector following FDA approval.
This is another important achievement in the development of Fresenius Kabi’s biosimilar pipeline, representing Fresenius Kabi’s first U.S. approved therapy in its biosimilar portfolio.
* Stimufend® (pegfilgrastim) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stimufend is a pegfilgrastim biosimilar medicine of Neulasta®, which is a registered trademark of Amgen Inc.
The European Medicines Agency (EMA) has accepted for review Fresenius Kabi’s Marketing Authorization Application (MAA) for MSB11456, a biosimilar candidate of RoActemra®*(tocilizumab). This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline, representing the company’s third biosimilar candidate submitted in the European Union. The MAA includes clinical data for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations.
*RoActemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
Fresenius Kabi introduces a three-year plan in the US to add two-dimensional (2D) barcodes to its pharmaceutical portfolio of vials, syringes, IV solutions and parenteral nutrition products. The initiative will help streamline workflows at health care facilities by reducing error-prone manual data entry in medication management systems. Fresenius Kabi is the first pharmaceutical company in the US to commit to offering 2D barcodes on all drug product labels. The US project marks an important milestone within the global product marking initiative of Fresenius Kabi, focusing on offering scannable products to support customer and patient needs.
The U.S. Food and Drug Administration (FDA) has accepted for review Fresenius Kabi's Biologics License Application (BLA) for MSB11456, a biosimilar candidate of Actemra®*(tocilizumab). This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline in the US. The BLA includes presentations for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations.
*Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, announced today that the U.S. Food and Drug Administration (FDA) has awarded 510(k) clearance to the Versi™PD Cycler System1. This next-generation portable automated peritoneal dialysis system from Fresenius Medical Care North America is the lightest, smallest and quietest dialysis cycler in the United States.
As the leading provider of kidney care products in the U.S., Fresenius Medical Care is developing new, innovative technologies designed to accelerate the growth of home therapies by making home dialysis systems smarter, more intuitive and easier to use for people living with kidney failure. VersiPD is simple, quiet, portable and advanced. VersiPD is also designed to improve health equity by making home therapy a more feasible option for a broader population of dialysis patients.
Designed from the ground-up to enhance the patient experience, VersiPD will allow patients to enjoy restful sleep through its almost silent operation, fewer disruptive alarms and night mode. The cycler has the capability of more personalized prescription programming to meet the individual needs of a broad range of patients. VersiPD offers a large, intuitively designed touchscreen as well as embedded videos with audio guidance to assist patients step-by-step through setup and treatment. The cycler battery and custom cart facilitate mobility around the home, which can further improve the patient’s quality of life.
VersiPD is supported by the Kinexus™ Therapy Management Platform, a connected health system that aims to improve patient outcomes and nurses’ productivity through remote therapy monitoring and programming capabilities. The Kinexus platform is also available with the Liberty® Select Cycler and is designed to be fully compatible with the company’s future portfolio of home dialysis machines. Connected health is associated with reduced rates of hospitalization, technique failure and patient dropout, and an increased average patient length of stay on peritoneal dialysis.2,3
A limited rollout of VersiPD will begin this year, with wider availability planned in 2023 and beyond. The company also plans to roll out VersiPD in other regions around the world in the future.
1 Previously known as Lilliput™ APD System
2 Chaudhuri S, Han H, Muchiutti C, et al. Remote Treatment Monitoring on Hospitalization and Technique Failure Rates in Peritoneal Dialysis Patients. Kidney360. 2020;1(3):191 LP - 202. doi:10.34067/KID.0000302019
3 Giles H, Ficociello L, Li Y, Ofsthun N, Kossmann R. Remote Patient Monitoring and Longevity on Peritoneal Dialysis [Abstract presented at 39th Annual Dialysis Conference]. Perit Dial Int. 2019;39(1_suppl): S4. doi:10.1177/089686081903901s01
Disclaimer:
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, impacts related to the COVID-19 pandemic results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius Kabi and the U.S. based company Cerus Corporation signed a new agreement for the production of systems for pathogen inactivation in blood components. The collaboration will help expanding access to pathogen-reduced blood components to patients. For many years, Cerus and Fresenius Kabi have collaborated regarding medical products specializing in pathogen inactivation for platelets and plasma. Since market launch of Cerus’ INTERCEPT systems, more than 11 million units have been in use worldwide.
Calcium Gluconate in Sodium Chloride Injection is now available in ready-to-administer non-DEHP, non-PVC containers, complementing the company’s existing vial presentations in the United States. Fresenius Kabi now has the broadest portfolio of Calcium Gluconate in Sodium Chloride Injection products available from any manufacturer in the United States.
The European Commission (EC) has granted Fresenius Kabi the marketing authorization for Stimufend®, the company’s pegfilgrastim biosimilar, for all approved indications of the reference medicine. Stimufend® stimulates the growth of certain white blood cells, which are essential to prevent or fight infections, a common life-threatening risk in patients receiving myelosuppressive chemotherapy. This is the company’s first approved biosimilar molecule used in oncology and its second biosimilar approved in Europe, expanding its autoimmune disease and oncology focused product portfolio.