First Biosimilar Filgrastim Launched Today

The first biosimilar to receive FDA approval is now available the United States.

Sandoz’s filgrastim-sndz (Zarxio) is biosimilar to Amgen’s filgrastim (Neupogen) biologic.

Neupogen was originally approved in 1991, while Zarxio was approved more than 2 decades later on March 6, 2015.

Both the biosimilar and its biologic reference product are approved to treat patients receiving myelosuppressive chemotherapy; those with acute myeloid leukemia receiving induction or consolidation chemotherapy; those undergoing bone marrow transplantation; those undergoing autologous peripheral blood progenitor cell collection and therapy; and those with severe chronic neutropenia.

Zarxio was approved for these 5 indications after structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other data demonstrated that it is highly similar to Neupogen.

Because Zarxio is not an interchangeable product, however, it cannot be substituted for Neupogen without health care provider intervention.

“While biologics have had a significant impact on how diseases are treated, their cost and co-pays are difficult for many patients and the health care budget in general,” stated Dr. Ralph Boccia, medical director of the Center for Cancer and Blood Disorders, and chief medical officer for the International Oncology Network. “Biosimilars can help to fill an unmet need by providing expanded options, greater affordability, and increased patient access to life-saving therapies.”

A recent report by Express Scripts estimated that more than $45 million was likely wasted for every month that Zarxio’s availability was delayed. Neupogen garnered $1.4 billion in sales last year, approximately 84% of which stemmed from the United States.

Litigation between Amgen and Sandoz delayed Zarxio’s release, but an appellate court ruling on July 21, 2015, gave the biosimilar the green light to reach the US market.

Another biosimilar application that the FDA accepted last year for Johnson & Johnson’s infliximab (Remicade) would bring relief to patients who use the drug for conditions such as rheumatoid arthritis and Crohn’s disease. Remicade sales reached $8.4 billion last year.

Express Scripts previously estimated that approximately $250 billion could be saved over the next decade if 11 biosimilars were to be approved.

With the first biosimilar now available, it will fall to manufacturers to launch awareness campaigns to increase the acceptance of these drugs among health care professionals and patients.