Sandoz launches ZarxioTM (filgrastim-sndz), the first biosimilar in the United States
- Launch follows March 6, 2015 FDA approval
- Sandoz One SourceTM offers patient support services
- Zarxio is an important oncology medicine for the treatment of neutropenia
Sandoz, a Novartis company, announced today that Zarxio™ (filgrastim-sndz) is now available in the United States. Zarxio is the first biosimilar approved by the US Food and Drug Administration (FDA) and the first to launch in the US.
“As the pioneer and global leader in biosimilars, Sandoz has maintained a commitment to bringing high-quality biosimilar medicines to patients and healthcare professionals around the world,” said Richard Francis, Global Head, Sandoz. “With the launch of Zarxio, we look forward to increasing patient, prescriber and payor access to filgrastim in the US by offering a high-quality, more affordable version of this important oncology medicine.”
“While biologics have had a significant impact on how diseases are treated, their cost and co-pays are difficult for many patients and the healthcare budget in general. Biosimilars can help to fill an unmet need by providing expanded options, greater affordability and increased patient access to life-saving therapies,” said Dr. Ralph Boccia, Medical Director of the Center for Cancer and Blood Disorders, and Chief Medical Officer for the International Oncology Network (ION).
Sandoz understands the importance of providing comprehensive patient support services in the oncology setting. With the launch of Zarxio, Sandoz is also proud to offer Sandoz One SourceTM a patient services center, providing support that connects the patient to the information and resources they need.
The launch follows the FDA approval of Zarxio on March 6, 2015. The approval, via the new biosimilars pathway established under the Biologics Price Competition and Innovation Act, was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that Zarxio is highly similar with no clinically meaningful differences to the US-licensed reference product. The successful Sandoz pivotal head-to-head PIONEER study was the final piece of data contributing to the totality of evidence used by FDA to approve Zarxio as biosimilar to the reference product. Importantly, the data demonstrating high similarity was sufficient to allow extrapolation of use of Zarxio to five indications of the reference product.
Actively involved in the initial stage of the development of recombinant filgrastim was also a mixed team of expert scientists from Lek and the National Institute of Chemistry under the leadership of Doctor Viktor Menart. The team, the majority of its members today employed at Biopharmaceutical Mengeš, was developing a technology for the preparation of recombinant filgrastim, and a part of the innovative technology was transferred into the production of biosimilar filgrastim in Austria. The technology for the preparation of recombinant filgrastim has been successfully established also across the Sandoz group and has been subject to patent applications. The development of the filgrastim pharmaceutical form was also carried out at Lek, a Sandoz company, where the first registration batches of the final filgrastim pharmaceutical form were manufactured and intended for use in Phase I clinical studies. The team of scientists at Biopharmaceuticals Mengeš and the National Institute of Chemistry Ljubljana received in November 2014 the Puh Award, one of the highest state recognitions in the area of scientific and research activities, for the development and production of the biosimilar medicinal products filgrastim and pegfilgrastim and their transfer into production.
Sandoz has an unwavering commitment to increasing patient access to high-quality, life-enhancing biosimilars. Sandoz is the global market leader and currently markets three biosimilars outside the US. Sandoz has a leading pipeline with several biosimilars across the various stages of development, including five programs in Phase III clinical trials/filing preparation.
The digital press release with multimedia content can be accessed here.
Lek, a Sandoz company, is one of key pillars of the second-largest generic pharmaceutical company globally. Its role within Sandoz is to act as: a leading global development center for technologically demanding products and technologies; a global manufacturing center for active pharmaceutical ingredients and medicines; a competence center for the development of vertically integrated products; a Sandoz competence center in the field of development and manufacturing of biosimilar products; and, a supply center for the markets of Central and Eastern Europe (CEE), South East Europe (SEE) and Commonwealth of Independent States (CIS), and it is responsible for sales on the Slovenian market. For further information please visit http://www.lek.si/en.
Sandoz, a division of Novartis, is a global leader in generic pharmaceuticals, driving sustainable access to high-quality healthcare. Sandoz employs more than 26,000 people worldwide and supplies a broad range of affordable products to patients and customers around the globe.
The Sandoz global portfolio comprises approximately 1,100 molecules, which accounted for 2014 sales of USD 9.6 billion. Sandoz holds the global #1 position in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines. Sandoz also holds leading global positions in key therapeutic areas ranging from generic injectables, dermatology and respiratory to cardiovascular, metabolism, central nervous system, pain and gastrointestinal.
Sandoz develops, produces and markets finished dosage form (FDF) medicines as well as intermediary products including active pharmaceutical ingredients (APIs) and biotechnological substances. Nearly half of the Sandoz portfolio is in differentiated products – medicines that are scientifically more difficult to develop and manufacture than standard generics.
In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has consistently driven growth in selected geographies and differentiated product areas through a series of targeted acquisitions, including Hexal (Germany), EBEWE Pharma (Austria), and Fougera Pharmaceuticals (US).
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Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and over-the-counter products. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 130,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit www.novartis.com.
This press release contains statements and conclusions based on projections of Lek’s future business operations. These estimates are derived from the best information currently available. In case these forecasts prove unreliable, the actual results could prove different from those projected.
For additional information contact:
Novartis Global Media Relations
Sandoz Global Communications
+49 (0) 162 429 7971
Lek Pharmaceuticals d. d.
Phone: +386 1 580 22 43
Fax: +386 1 580 24 32