First Biosimilar Now Available in United States


Cancer therapy filgrastim-sndz (Zarxio) was initially approved on March 6, 2015.

Cancer therapy filgrastim-sndz (Zarxio) was initially approved on March 6, 2015.

Today marks a milestone in the pharmaceutical landscape that may eventually make high cost specialty drugs more affordable.

The first biosimilar ever approved in the United States, filgrastim-sndz (Zarxio), is now available following its initial approval on March 6, 2015.

Zarxio, manufactured by Sandoz, Inc, is biosimilar to Amgen Inc’s Neupogen (filgrastim), which was originally approved in 1991. Zarxio was approved for the same indications as Neupogen, for the treatment of patients receiving myelosuppressive chemotherapy; those with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients undergoing bone marrow transplantation; those undergoing autologous peripheral blood progenitor cell collection and therapy; and those with severe chronic neutropenia.

“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 of Sandoz. “With the launch of Zarxio, we look forward to increasing patient, prescriber and payor access to filgrastim in the United States by offering a high quality, more affordable version of this important oncology medicine.”

Zarxio was approved following an evaluation of the structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other data that showed it is biosimilar to Neupogen. The drug is not an interchangeable product, however. A biological product approved as interchangeable may be substituted for the reference product without health care provider intervention.

The delayed release of Zarxio occurred as a result of litigation between Amgen and Sandoz. However, after an appeals court ruling on July 21, 2015, Zarzio officially hits the US market today. Neupogen garnered $1.4 billion in sales last year, with approximately 84% of those sales in the United States.

A recent report by Express Scripts estimates more than $45 million was likely wasted for every month Zarxio was delayed from hitting the market.

“Biosimilars will do for the biotech market, primarily made up of very expensive injectable drugs, what generic drugs did for traditional oral solid pills a decade ago: lower the cost for safe, effective treatments that improve and save lives,” Express Scripts wrote in the report. “They will revolutionize the category of spending that is among the fastest-growing and most worrisome for payers who want to continue providing sustainable, high-quality benefits for their members.”

Another biosimilar application accepted by the FDA last year for infliximab (Remicade) by Johnson & Johnson would bring relief to consumers 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 the drugs among physicians and patients.

“We are all learning about biosimilars because it’s an emerging area that is evolving very rapidly, especially for the patients who are the most important part of this chain of groups that work together,” said Javier Coindreau, MD, vice president of global medical affairs for Pfizer Biosimilars Business Unit, in an interview with Specialty Pharmacy Times. “Patients need to learn how biosimilars are developed, what are the advantages and disadvantages, what are the safety and efficacy issues of each one of the different biosimilars that will appear in the market.”

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