GERMANY —Fresenius Kabi, a renowned global healthcare company specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs, has achieved a major milestone with its tocilizumab biosimilar candidate MSB11456.
Referencing the well-established RoActemra (tocilizumab), the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion, paving the way for marketing authorization.
This approval marks MSB11456 as the first tocilizumab biosimilar candidate to receive such an endorsement from CHMP, opening new possibilities in treating various autoimmune diseases.
Disease indications include rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
Additionally, it holds promise for the treatment of cytokine release syndrome and COVID-19.
The European Medicines Agency defines biosimilars as medicinal products that contain a version of the active substance found in an already authorized original biological medicinal product within the European Economic Area.
This positive opinion encompasses both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations, providing patients treated with tocilizumab, a comprehensive alternative treatment solution.
Pierluigi Antonelli, the CEO of Fresenius Kabi, expressed the company’s strong commitment to enhancing the quality of life for critically and chronically ill patients.
As part of its Vision 2026 strategy, Fresenius Kabi continues to expand its biopharma portfolio, ensuring essential treatment options are available worldwide.
The company has also invested significantly in its biosimilars business, producing cost-effective versions of complex biotech drugs that have lost patent protection.
Its venture into the United States market has already begun, bringing more accessible healthcare solutions to patients.
Tocilizumab, a humanized IgG1 antibody targeting the Interleukin-6 (IL-6) receptor (IL-6R), has been approved for treating various inflammatory diseases.
It gained further prominence during the COVID-19 pandemic, renewing global interest in the production of Actemra biosimilars.
While the demand for more affordable monoclonal antibody biosimilars continues to rise, their development and manufacture pose challenges due to intricate manufacturing procedures and stringent regulatory requirements.
Nonetheless, since the authorization of the first biosimilar in Europe in 2006, the EMA has granted positive opinions to over 40 biosimilars, and the number is expected to grow substantially in the future.
These biosimilars, especially in oncology, can lead to significant savings by introducing price competition and offering more affordable treatment options.
Cumulatively, the estimated savings between 2016 and 2020 in the EU5 and the USA ranged from 49 to 98 billion Euros, (US$54.3 billion to US$108.6 billion) easing the burden on healthcare budgets and expanding patient access to biological therapies.
Fresenius Kabi operates through four main branches, including Fresenius Kabi (the pharma division), Fresenius Medical Care (FMC) (its dialysis business), Vamed (the group’s hospital project development arm), and Helios (a private hospital operator).
While Fresenius Kabi and Fresenius Helios have demonstrated robust growth, FMC faced compound difficulties, particularly during the COVID-19 pandemic, which led to a substantial number of patient fatalities and widespread staff shortages in the US.
The inflationary pressures added to the challenges, forcing the firm to revise its annual outlook twice last year, impacting the broader group’s forecasts.
As part of its new strategy, Fresenius Kabi acquired Ivenix, a US-based infusion systems company, to enhance its intravenous drug offerings.
Additionally, the company took a majority stake in Spanish biosimilar developer mAbxience, further strengthening its biosimilars portfolio.
Despite these efforts, FMC remains a primary concern, prompting Fresenius to announce its decision to relinquish control over the struggling dialysis unit while maintaining a 32 percent stake, possibly signaling future plans to unload the company.
Fresenius Kabi’s comprehensive patient support program, KabiCare, will be available to patients and healthcare providers in the EU from the launch of MSB11456.
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