FDA Approves Biosimilar Treatment for Cancer-Related Neutropenia
The FDA approved the Biologics License Application for a biosimilar version of pegfilgrastim, according to a release from the manufacturer.
The release noted pegfilgrastim-pbbk is a leukocyte growth factor approved to decrease the incidence of infection caused by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
However, the treatment is not indicated for mobilizing peripheral blood progenitor cells for hematopoietic stem cell transplantation.
The most common adverse reactions reported with the medication include bone pain and extremity pain.
“Building on our successful partnership with the recent approval of our first biosimilar, [filgrastim-ayow), we are pleased to receive approval for our second biosimilar,” Chandramauli Rawal, MD, COO, and head of biosimilars at Kashiv, said in the release.
Reference:
https://investors.amneal.com/news/press-releases/press-release-details/2022/Amneal-Achieves-Third-U.S.-Biosimilar-Approval-with-FYLNETRA-pegfilgrastim-pbbk/default.aspx
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By Adam Hochron, Staff Writer