The era of biosimilars in the United States is officially coming! Novartis zarxio officially launched!

Source: Biovalley, September 6, 2015 Sandoz, a generic unit of Novartis, a Swiss pharmaceutical giant, recently announced the launch of zarxio (filgrastim sndz, feigerstim sndz) in the United States, which is a bio generic of the Amgen heavyweight drug neupogen (filgrastim, feigerstim), in 2015 It was approved by FDA on March 6, 2006, and is the first real biological generic drug in the history of the United States The listing of zarxio also marks the official arrival of the era of biosimilars in the United States In terms of price, Novartis priced zarxio 15% lower than the original research drug neupogen At present, although the U.S is trying to catch up with other markets (such as Europe, Australia and India) in which biosimilars have made great progress, it remains to be seen how high zarxio can reach and how quickly the market can be accepted Novartis CEO Joe Jimenez said Thursday that zarxio's sales are not expected to make a big leap by 2020, which is in line with the opinion of industry analysts Neupogen is a blockbuster drug of Amgen, with global sales of US $1.16 billion in 2014, including US $839 million, accounting for more than 70% Neupogen was first approved by FDA in 1991 and is currently used in treatment 5 Neutropenia in cases including: cancer patients receiving chemotherapy with bone marrow inhibitors, acute myeloid leukemia patients receiving induction chemotherapy or consolidation chemotherapy, cancer patients undergoing bone marrow transplantation, patients undergoing autologous peripheral blood stem cell collection and treatment, and patients with severe chronic neutropenia Zarxio is the first biosimilars approved by a new biosimilars approach created by the bpcia of the United States The approval of zarxio is based on a complete data package including analytical data, non clinical data and clinical data, which proves that zarxio and the original drug neupogen have no significant difference in clinical significance More importantly, data from one of the key peer-to-peer pioneer studies confirm that this high degree of similarity is sufficient to allow the use of zarxio to be extrapolated to all five indications of the reference drug neupogen It should be noted that the FDA approved zarxio (filgrastim sndz) for all five indications of the original drug neupogen (filgrastim), but did not approve its interchangeability with neupton, which also means that zarxio can not be used to replace the original drug neupogen, if filgrastim does not specify sndz in the doctor's prescription Suffix, the pharmacist can only take the original drug neupogen to the patient As a pioneer and global leader in the field of biosimilars, Sandoz has always been committed to providing high-quality biosimilars for patients and medical experts around the world, and the company also has a deep understanding of the importance of providing comprehensive support services for cancer patients With the listing of zarxio, the company also launched Sandoz one sourcetm patient service center to provide support services for patients to obtain required information and resources.