- Tyenne® is the first tocilizumab biosimilar available with both
an intravenous and subcutaneous formulation approved by the
FDA.
- The subcutaneous formulation of the tocilizumab biosimilar
provides increased access and an affordable treatment option for
U.S. patients.
- Subcutaneous formulation was approved by FDA and is available
in a self-administered prefilled syringe and an autoinjector.
- Third Fresenius Kabi biosimilar in the U.S. and second in its
immunology portfolio.
Fresenius, via its operating company Fresenius Kabi, announced
today the immediate availability in the U.S. of its biosimilar
Tyenne® (tocilizumab-aazg), in a subcutaneous formulation, which
will increase access to affordable and cost-effective treatment
options for use in the treatment of chronic autoimmune
diseases.
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Tyenne® from Fresenius Kabi is the first
tocilizumab biosimilar approved by the FDA that is available in
both an intravenous and subcutaneous formulation. The subcutaneous
formulation is now available in a self-administered prefilled
syringe and an autoinjector. (Photo: Business Wire)
Tyenne is indicated for use in the treatment of chronic
autoimmune diseases for certain indications of the reference
product, Actemra® (tocilizumab). Fresenius Kabi previously launched
Tyenne® in an intravenous (IV) formulation in April of this
year.
“After successfully launching Tyenne in more than 10 countries,
we are on track to continue the momentum in the U.S with the launch
of a second formulation,” said Sang-Jin Pak, M.D., President of
Biopharma at Fresenius Kabi. “Introducing our subcutaneous
formulation demonstrates our continued commitment to providing
greater access to more patients living with autoimmune
diseases.”
Trial data that compared Tyenne® to the reference product,
Actemra® showed similar safety and tolerability.
Tyenne® is the first tocilizumab biosimilar with an intravenous
and subcutaneous formulation approved by the FDA. Tyenne® received
FDA approval on March 5, 2024, and an IV formulation was launched
in April 2024 for use in the treatment of several inflammatory
autoimmune diseases, including rheumatoid arthritis, giant cell
arteritis, polyarticular juvenile idiopathic arthritis, and
systemic juvenile idiopathic arthritis.
To learn more about how Fresenius Kabi provides comprehensive
patient support for Tyenne® in the U.S. please click here.
About Tyenne®, a Tocilizumab Biosimilar
Tyenne® (tocilizumab-aazg), a biosimilar to Actemra®
(tocilizumab), is a prescription medicine called an Interleukin-6
(IL-6) receptor antagonist. It was developed by Fresenius Kabi
using advanced analytical and manufacturing technologies for use in
the treatment of several autoimmune diseases, including rheumatoid
arthritis, giant cell arteritis, polyarticular juvenile idiopathic
arthritis, and systemic juvenile idiopathic arthritis. Tyenne®
includes a Boxed Warning for serious infections leading
to hospitalization or death including tuberculosis (TB), bacterial,
invasive fungal, viral, and other opportunistic infections that
have occurred in patients receiving tocilizumab products.
Tyenne® is contraindicated in patients with known hypersensitivity
to tocilizumab products. For more information about Tyenne®, please
see the important safety information and full prescribing
information for the U.S.
About Fresenius Kabi
Fresenius Kabi is a global healthcare company that specializes
in lifesaving medicines and technologies for infusion, transfusion
and clinical nutrition. The company’s products and services are
used for the therapy and care of critically and chronically ill
patients.
Its product portfolio comprises a range of highly complex
biopharmaceuticals, clinical nutrition, medical technologies, and
I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi
offers, among others, biosimilar drugs with a focus on autoimmune
diseases and oncology. The company’s clinical nutrition offering
includes a wide selection of enteral and parenteral nutrition
products. In the segment of medical technologies, its offering
includes vital disposables, infusions pumps, apheresis machines,
cell therapy devices, and more. Fresenius Kabi puts essential
medicines and technologies in the hands of people who help patients
and finds the best answers to the challenges they face.
Following its strategy “Vision 2026”, which is a key part of the
#FutureFresenius program of the Fresenius healthcare group, the
company is furthermore committed to increase efficiencies in the
therapy and care of patients and improve access to high-quality
healthcare around the globe. Fresenius Kabi aspires to be leader
globally in its product segments – all for the benefit of patients,
its customers, and its stakeholders.
Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global
healthcare company headquartered in Bad Homburg v. d. H�he,
Germany. In the 2023 fiscal year, Fresenius generated €22.3 billion
in annual revenue with its more than 190,000 employees. Fresenius
offers solutions to the social challenges posed by a growing and
ageing population and the resulting need for affordable,
high-quality healthcare. The Fresenius Group comprises the
operating companies Fresenius Kabi and Fresenius Helios as well as
the investment companies Fresenius Vamed and Fresenius Medical
Care. With 140 hospitals and countless outpatient facilities,
Fresenius Helios is the leading private hospital operator in
Germany and Spain, treating around 26 million patients every year.
Fresenius Kabi’s product portfolio
includes a range of highly complex biopharmaceuticals, clinical
nutrition, medical technology, and generic intravenous drugs.
Fresenius was established in 1912 by the Frankfurt pharmacist Dr.
Eduard Fresenius. After his death, Else Kr�ner took over management
of the company in 1952. She laid the foundations for a global
enterprise that today pursues the goal of improving people’s
health. The largest shareholder is the non-profit Else
Kr�ner-Fresenius Foundation, which is dedicated to advancing
medical research and supporting humanitarian projects.
For more information visit the company website at
www.fresenius.com. Follow us on social media:
www.fresenius.com/socialmedia.
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, the availability of
financing and unforeseen impacts of international conflicts.
Fresenius does not undertake any responsibility to update the
forward-looking statements in this release.
Fresenius SE & Co. KGaA Registered Office: Bad Homburg,
Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch
General Partner: Fresenius Management SE Registered Office: Bad
Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg,
HRB 11673 Management Board: Michael Sen (Chairman), Pierluigi
Antonelli, Sara Hennicken, Robert M�ller, Dr. Michael Moser
Chairman of the Supervisory Board: Wolfgang Kirsch
Actemra® is a registered trademark of Chugai Seiyaku Kabushiki
Kaisha Corp., a member of the Roche Group.
Tyenne® is a registered trademark of Fresenius Kabi Deutschland
GmbH.
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Matt Kuhn (847) 220-3033 matt.kuhn@fresenius-kabi.com