USFDA nod to Mylan and Biocon's biosimilar of cancer drug Neulasta

The US health regulator has approved Mylan's cancer treating biosimilar Fulphila co-developed with Biocon, the companies said today.

Fulphila is the first US Food and Drug Administration (USFDA) approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon's joint portfolio approved in the US, they said in a joint statement.

"Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer," Biocon said in a regulatory filing.

Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients.

Mylan has a portfolio of 20 biosimilar and insulin analog products.

Quoting IQVIA data, Biocon said Neulasta had US sales of USD 4.2 billion for the 12 months ended March 31, 2018.

Biocon said biosimilar medicines are deemed by 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 USD 54 billion in direct spending on biologic drugs in the US between 2017 and 2026," it added.

Shares of Biocon were trading 0.62 per cent higher at Rs 658.15 apiece on BSE.