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Biosimilar for cancer drug Neupogen approved by FDA




Patients with neutropenia may have improved access to treatment following the US Food and Drug Administration’s (FDA’s) approval of Nivestym (filgrastim-aafi), a biosimilar for Amgen biologic Neupogen (filgrastim). 

The FDA’s approval of the biosimilar was based on a review of data provided by Pfizer, the manufacturer of the product. It is fourth biosimilar product for which the firm has gained approval and the eleventh biosimilar approved by the FDA in 2018 thus far, although only three are currently marketed in the US. 

Nivestym is a colony stimulating factor used to stimulate the growth of certain white blood cells called neutrophils, which are important in fighting off infections, yet are deficient in patients with neutropenia. This condition is more common in patients with conditions affecting the bone marrow, such as leukemia. It is used to reduce incidences of fever and infection in patients undergoing chemotherapy that affects the bone marrow.  

The medication is administered via intravenous or subcutaneous injection by a healthcare provider, although providers may decide subcutaneous injections can be administered by patients or caregivers at home. The most common side effect of Nivestym is aching muscles and bones. 

Other possible serious side effects include ruptured spleen, acute respiratory distress syndrome, sickle cell crises, kidney injury, capillary leak syndrome, lower platelet levels, leukocytosis (increased white blood cell count), and inflammation of the blood vessels. 

In comments earlier this month about the FDA’s new Biologics Action Plan (BAP), the agency’s Commissioner Scott Gottlieb recently asserted that biologics accounted for 70 percent of the growth in drug spending between 2010 and 2015, stating: “Our ability to build a market for safe, effective biosimilar products is key for patients and our nation’s health care system.”

Following the lessons learned from increasing the generics market, Gottlieb laid out four key strategies under the BAP. These were improving the efficiency of biosimilar and interchangeable product development and approval; maximizing regulatory and scientific clarity for those developing biosimilars; improving understanding of biosimilars among patients, healthcare providers and payers; and taking steps to support market competition and “reduce gaming of FDA requirements”.