Fresenius Kabi AG
|Applicable indicator||Not applicable|
Fresenius Kabi is a prominent producer of antibiotics globally by sales volume. As a generic medicine manufacturer, Fresenius Kabi was evaluated in Manufacturing & Production and Appropriate Access & Stewardship only. The company is among the top performing generic medicine manufacturers. It discloses an environmental risk-management strategy for its own sites. Fresenius Kabi reports mechanisms for maintaining a high quality of antibiotic production and also requires its third-party suppliers of drug products to apply the same quality standards to their production facilities. Fresenius Kabi reports information on where it files antibiotics for registration; however, there is no information available regarding the company’s approach to equitable pricing for its highest- volume antimicrobial medicines. Regarding stewardship, the company reflects AMR trends in its marketing materials through leaflets on AMR-related topics for its top marketed products.
Sales & operations
Fresenius Kabi is a wholly owned subsidiary of Fresenius SE & Co. KGaA, and specialises in medicines and technologies for infusion, transfusion and clinical nutrition in the field of critical and chronic care. It has four business segments: intravenous (IV) drugs; infusion therapy; clinical nutrition; and medical devices & transfusion technology. Its IV drugs segment includes anti-infectives. In 2017, Fresenius Kabi announced that it would acquire Akorn Inc., a US-based manufacturer and marketer of prescription and over-the-counter ophthalmic, injectable and specialty sterile and non-sterile pharmaceuticals. Also in 2017, the company completed the acquisition of Merck KGaA’s biosimilars business, whose product pipeline focused on oncology and autoimmune diseases. Fresenius Kabi markets its antimicrobial medicines in 34 countries globally, six of which are low- or middle-income countries.* All of the company’s antimicrobial medicines are infusion or powder-for-injection formulations.
Fresenius Kabi markets at least 35 antimicrobial medicines, 21 of which are listed on the WHO EML (Section 6). Thirty-two of the company’s antimicrobial medicines are antibiotics, with 19 listed on the WHO EML (Section 6), including five in the EML’s Reserve group (aztreonam, cefepime, daptomycin, linezolid and tigecycline). The remaining three medicines are an antifungal (fluconazole) and the antivirals aciclovir and ganciclovir, indicated for infections caused by herpes virus and cytomegalovirus, respectively.
Increase engagement in antimicrobial stewardship. Fresenius Kabi adopts some appropriate promotion practices through leaflets on AMR-related topics for its top marketed products. It can engage in more stewardship activities, e.g., through surveillance activities, educational activities for healthcare professionals on AMR (while mitigating conflict of interest), and expand on appropriate promotion practices.
Improve access to new and existing antimicrobials. Fresenius Kabi can file its new and existing antimicrobials for registration in more countries. Fresenius Kabi has filed two of its newest antibiotics for registration in countries in scope.* The company can also seek to improve access in low- and middle-income countries by ensuring its new and existing antimicrobials are priced affordably.
Improve transparency regarding environmental risk. Fresenius Kabi can share more information on how it manages environmental risk, e.g., the company can publish the results of audits carried out on its environmental risk-management strategy. Fresenius Kabi already discloses environmental risk principles.
Expand its environmental risk-management strategy. Fresenius Kabi can ensure its environmental risk-management strategy is extended to the sites of third parties who manufacture antibiotic APIs and drug products on its behalf. Fresenius Kabi currently has an environmental risk-management strategy, that includes auditing processes, and is applied to its own manufacturing sites.
Engage in R&D innovation. Fresenius Kabi can engage further in incremental R&D innovation to address resistance and improve appropriate use of antimicrobial medicines. The company already engages in incremental R&D directed at improving usability of its medicines by HCPs.
A. Research & Development
As a generic medicine manufacturer, Fresenius Kabi’s main focus is the manufacturing of generic products and as such was not in scope for this Research Area.
B. Manufacturing & Production
B.1 Environmental risk-management strategy for own sites.
Fresenius Kabi has a general environmental risk-management strategy to minimise the impact of antibiotic manufacturing discharge. This applies to its own manufacturing sites and includes audits. There is no information suggesting that the strategy is applicable to third-party manufacturers of antibiotic APIs and drug products or to external waste-treatment plants. The company reports no information about setting discharge limits.
B.2 Limited transparency regarding environmental risk management.
Fresenius Kabi publishes its environmental risk-management principles in its annual report. It does not disclose audit results, or the discharge levels of antibiotics. The company also does not share the identities of its third-party suppliers of antibiotic APIs and drug products, or external waste-treatment plants.
B.3 Commits to following GMP, including at 3rd-party sites.
Fresenius Kabi reports that it has mechanisms for maintaining a high quality of antibiotic production — namely following GMP standards. This commitment applies to its own manufacturing sites. Fresenius Kabi requires its third-party suppliers to apply the same quality standards to their production facilities.
C. Appropriate Access & Stewardship
C.1 Some newest antibiotics filed in some countries in scope.
Fresenius Kabi reports information about where it has filed some of its newest antibiotics for registration in some countries in scope.* However, the Benchmark is not able to publish further information, as all details were provided on the basis of confidentiality.
C.2 No information available on equitable pricing approach.
There is no information available regarding Fresenius Kabi’s approach to equitable pricing for its highest-volume antibiotics and/or antimicrobial medicines.
C.3 No insight into steps addressing supply chain efficiency.
Fresenius Kabi does not disclose how it works with stakeholders (e.g., governments, procurers) to align supply and demand for antimicrobial medicines, specifically to prevent or minimise stock-outs in countries in scope.* The company also does not report on whether it has processes in place to respond to stock-outs in countries in scope.*
C.4 No information on AMR-related education.
There is no information available regarding Fresenius Kabi’s involvement in AMR-related educational activities for HCPs.
C. 5 Adopts some appropriate promotion practices.
The Benchmark measures how companies address stewardship through appropriate promotion practices. Fresenius Kabi is one of two generic medicine manufacturers that reports taking action in this regard by reflecting AMR trends in its marketing materials. For example, the company created, for its top marketed products, leaflets aimed at informing HCPs on AMR-related topics. These leaflets include AMR-related information under the “Special Warnings and Precautions for Use” section. There is no information available on decoupling of the company’s sales force’s incentives from volume of antibiotic sales.
C.6 No antibiotics dispensed directly to patients.
Fresenius Kabi is not eligible for this indicator as it does not have any antibiotics in its portfolio that are directly dispensed to patients. All of its antibiotics are administered in the hospital.
C.7 No information regarding AMR surveillance programmes.
There is no information available regarding Fresenius Kabi’s efforts to engage in AMR surveillance programmes.
* Countries in scope are 106 low- and middle-income countries where access to medicine is likely limited
† EML Section 6: Anti-Infective Medicines
§ Sales, FYE 31 December 2016