First Biosimilar Pegfilgrastim Gets FDA Approval
Mylan and Biocon announced that the Food and Drug Administration (FDA) has approved Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim; Amgen), to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
The approval was supported by nonclinical and clinical data (including pharmacokinetic, pharmacodynamic, clinical immunogenicity, structural and functional characterization data), which demonstrated Fulphila was highly similar to Neulasta. No clinically meaningful differences in safety, purity, and potency between the biosimilar product and Neulasta were noted, however Fulphila has not been approved as an interchangeable product.
Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
Fulphila will be available as a 6mg/0.6mL single-dose prefilled syringe for subcutaneous (SC) injection. It is anticipated to launch in the coming weeks.
For more information call (877) 446-3679 or visit Mylan.com.