Mylan N.V. and Biocon announced on Tuesday that the U.S. Food and Drug Administration has approved Mylan’s Fulphila, a biosimilar to Neulasta, co-developed with Biocon to treat low count of neutrophils in patients undergoing chemotherapy in certain types of cancer.
A suite of patient services also will be available after the introduction of the medicine to further support patients and caregivers with treatment, according to a BSE filing. Neulasta had U.S. sales of $4.2 billion for the 12 months ending March 31, 2018, according to IQVIA, a clinical research firm.
Biosimilar medicines are deemed by the USFDA to be highly similar to an already-approved biologic product. They fill an urgent and unmet need for more affordable alternatives to biologic therapies, increasing access and providing savings for patients and the overall healthcare system.
It is projected that biosimilars will generate a savings of $54 billion in direct spending on biologic drugs in the U.S. between 2017 and 2026, according to the filing.