Sandoz launches ZarxioTM (filgrastim-sndz), the first biosimilar in the United States

“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.