Fresenius Kabi has submitted a Marketing Authorization Application to the European Medicines Agency for its adalimumab biosimilar candidate of Humira®. The application is the first biosimilar regulatory filing for Fresenius Kabi. Adalimumab is approved in the EU for use in the treatment of chronic inflammatory autoimmune conditions, including different types of arthritis or Crohn's disease.

Fresenius Medical Care, the world’s largest provider of dialysis products and services, today announced the closing of the divestment of Shiel Medical Laboratory, Inc. to Quest Diagnostics, Inc. as of December 7, 2017. This milestone follows the expiration of the comment period under the Hart-Scott-Rodino Antitrust Improvements Act.

Shiel provided comprehensive non-dialysis laboratory services in the New York-New Jersey metropolitan area. Its divestment is aligned with Fresenius Medical Care’s goal of further optimizing the company’s Care Coordination portfolio. Spectra Labs, the dialysis-related laboratory services business of Fresenius Medical Care, is not affected by the divestiture.

Fresenius Kabi opened the extension of its production plant in Mihla, Germany, today with a festive dedication ceremony attended by Mayor Rainer Laemmerhirt. The healthcare company invested about €10 million in the project.

In the new production hall, employees will make core injection-molded components for pharmaceutical containers, port systems – which enable infusions to be administered as gently as possible, for example during chemotherapy – and medical disposables. The latter include such products as feeding tubes and giving sets, which are routinely used in hospitals to administer infusion therapies, clinical nutrition and intravenous drugs. The extension will enable Fresenius Kabi to produce components it previously had to purchase from suppliers.

At approximately 1,000 square meters (10,700 square feet), the new hall doubles the amount of space available for production activities at the plant in Mihla, a town in the eastern German state of Thuringia. The project also includes an expansion of the plant’s warehouse to hold as many as 2,000 pallets – a more than six-fold increase.

Dr. Christian Hauer, President Medical Devices Division of Fresenius Kabi, said: “Products from Fresenius Kabi are used in the care of chronically and critically ill patients, which makes the highest standards of quality and reliability essential. Our employees in Mihla have been doing outstanding work for many years. I’m delighted that with this extension, we are making our Mihla production location ready for the future.”

Mayor Laemmerhirt praised Fresenius Kabi for its commitment to his community: “I am very happy that Fresenius Kabi, as a globally active company, is investing here in Mihla. This can also be seen as a positive sign for our region and its economic development.”

Fresenius Medical Care, the world’s largest provider of dialysis products and services, announced today the results from the first performance year from its End Stage Renal Disease Seamless Care Organizations (ESCOs). The results, which cover the period from October 2015 through December 2016, show improved health outcomes for patients receiving care coordination through the ESCOs. This success was validated by an independent report from Lewin Group, which showed a nearly nine percent decrease in hospitalization rates for these patients during the same time. As a result, Fresenius Medical Care ESCOs together generated more than $43 million in gross savings, an average 5.47% reduction in expenditures per patient, with all six of its first-year ESCOs exceeding the shared savings benchmark.

Fresenius Medical Care’s ESCO programs were established through an agreement with the Centers for Medicare & Medicaid Services (CMS) as part of CMS’ Comprehensive End Stage Renal Disease (ESRD) Care (CEC) Demonstration Program. Launched in 2015, it is the first disease-specific shared savings program in the United States. This program was designed to identify, test and evaluate new ways to improve care and healthcare cost for Americans with ESRD.

The first-year report includes results of Fresenius Medical Care’s first six ESCOs, including 176 clinics and 386 physician partners in Philadelphia, Pa.; Charlotte, N.C.; Dallas, Texas; San Diego, Calif.; Columbia, S.C. and Chicago, Ill. In January 2017, Fresenius Medical Care added 18 new ESCOs for a total of 24, expanding to nearly 800 physician partners and giving the company the largest ESCO presence of any dialysis provider in the United States.

“Participation in the ESCO program reinforces our support of physicians and the healthcare system to improve care and reduce costs,” said Rice Powell, Chairman and CEO of Fresenius Medical Care. “We are excited about our results and pleased that CMS has provided us with the opportunity to expand our services to cover even more patients.”

CMS conducted an application process to select the participants in the ESCO program. ESCO patients, or beneficiaries, are aligned to ESCOs through a claims-based process, and maintain their full Medicare benefits as well as the freedom to choose their providers. The program uses a shared savings and losses model as a financial incentive to improve care, assessed by a baseline that looks at expenditures incurred for beneficiaries in each of the three years prior to the start of the program. In the first program year, there were 16,085 beneficiaries aligned to the thirteen participating ESCOs.

Fresenius Kabi is expanding its activities in Indonesia. PT ETHICA Industri Farmasi, a joint venture of Fresenius Kabi and the Indonesian pharmaceuticals company SOHO Global Health, opened a new plant in Cikarang, just outside the country’s capital and biggest city Jakarta. The plant’s approximately 230 employees will produce a wide range of injectable drugs needed in therapeutic areas including gynecology, anesthesia and intensive care. The products are planned for use by Indonesian patients and for export to other Southeast Asian countries. Fresenius Kabi employs a total of about 530 people in Indonesia.

Fresenius Kabi is expanding its activities in Indonesia. PT ETHICA Industri Farmasi, a joint venture of Fresenius Kabi and the Indonesian pharmaceuticals company SOHO Global Health, opened a new plant in Cikarang, just outside the country’s capital and biggest city Jakarta. The plant’s approximately 230 employees will produce a wide range of injectable drugs needed in therapeutic areas including gynecology, anesthesia and intensive care. The products are planned for use by Indonesian patients and for export to other Southeast Asian countries. Fresenius Kabi employs a total of about 530 people in Indonesia.