Singapore: Sandoz, a Novartis company, has received USFDA approval to launch first biosimilar drug, Zarxio (filgrastim-sndz), in 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 Mr 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, Center for Cancer and Blood Disorders, and Chief Medical Officer for the International Oncology Network (ION).
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.
