First long-acting biosimilar to help reduce infection risk during cancer treatment receives FDA approval

First long-acting biosimilar to help reduce infection risk during cancer treatment receives FDA approval

The U.S. Food and Drug Administration (FDA) recently approved Fulphila (pegfilgrastim-jmdb), the first biosimilar to Neulasta, to help reduce the risk of infection during cancer treatment.

Like Neulasta, Fulphila helps reduce the chance of infection due to low white blood cell count in people with non-myeloid (non-bone marrow) cancer who receive intensive chemotherapy. Unlike Neulasta, Fulphila does not have an indication for increasing survival in patients exposed to radiation.

The most common side effects of Fulphila are bone and extremity pain. Serious side effects include rupture of the spleen, acute respiratory distress, serious allergic reactions, abnormally high levels of white blood cells and the potential for tumor growth. Fulphila prescribing information is available here.

Market Availability & Costs

Analysts expect Fulphila to compete with Neulasta, which reached annual sales of nearly $4 billion in 2017 in the United States. Pricing for Fulphila has not been released. However, based on previous biosimilar market releases, Fulphila is anticipated to be priced 15% to 35% less than Neulasta.

To date, the FDA has approved 11 biosimilars, but only three are commercially available: Zarxio (filgrastim-sndz), Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda). The FDA approved biosimilars for Enbrel, Humira, Herceptin and Avastin, but they are not available commercially yet.

The FDA approved Fulphila as a biosimilar, but not as an interchangeable product. Additional studies are required before it is considered interchangeable. Currently, the FDA has not approved any biosimilar as interchangeable. 

Forward-Thinking Strategies to Manage Drug Costs

MedImpact is in communication with the manufacturer regarding its future availability and expects it to be available in the upcoming weeks.

MedImpact’s Pharmacy and Therapeutics Committee will conduct a review of Fulphila at their next quarterly meeting. Upon receiving pricing information and reviewing effective cost management strategies, MedImpact will make final recommendations regarding formulary placement and utilization management.

To learn more about how MedImpact can help you manage high-impact, high-cost drugs, reduce costs and improve care, go to

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