Mylan and Biocon's Fulphila has become the first biosimilar of Amgen's Neulasta to be approved by the US Food and Drug Administration.
Neulasta (pegfilgrastim) is a long-acting formulation of filgrastim (granulocyte colony-stimulating factor), which generated US sales of $4.2 billion for the 12 months ending March 31 this year.
Fulphila has been approved for the same indication as its reference product, that is to reduce the duration of febrile neutropenia in patients treated with chemotherapy.
Mylan anticipates launching the drug in the coming weeks, “representing the first alternative, more affordable treatment option to Neulasta for oncology patients”.
The firm also said that a “suite of patient services” will be available at launch to offer further support to patients and caregivers with the treatment.
“FDA’s approval of this product, as well as the agency’s continued focus on biosimilars, mark crucial steps towards lowering treatment costs and providing alternative options for patients,” said Mylan chief executive Heather Bresch.
“Mylan is committed to offering affordable and accessible solutions for patients with cancer at every step of their journey. Enhancing access to treatment has always been our top priority and what we’ll continue to deliver to the healthcare system in the US and beyond.”