WASHINGTON -- The first for sale under the name Fulphila, the FDA said Monday.
The original drug is sold as Neulasta. Fulphila, made by Mylan, is approved for use in patients at high risk for infection due to neutropenia as a result of myelosuppressive chemotherapy. Both agents are synthetic versions of human granulocyte colony-stimulating factor.
Clinical trials and animal and laboratory established that Fulphila (with official generic name pegfilgrastim-jmdb) is functionally equivalent to Neulasta in terms of clinical efficacy, safety, pharmacodynamics, and pharmacokinetics. However, the biosimilar is not approved to be interchangeable with the original agent, which would require a different and more elaborate set of studies.
Side effects of Fulphila are similar to those seen with Neulasta: most commonly bone pain and pain in extremities.
In fiscal 2017, , according to manufacturer Amgen. List prices for biosimilars have generally been lower than those for originator drugs, though not dramatically so. Thus far, makers of originator drugs have mostly succeeded in protecting their franchises through deals with insurers and pharmacy benefit managers.