Regulatory Affairs

Mylan, Biocon secure FDA nod for first biosimilar to cancer drug Neulasta

PBR Staff Writer Published 05 June 2018

Mylan and Biocon have secured approval from the US Food and Drug Administration for Fulphila (pegfilgrastim-jmbd), a biosimilar to Amgen’s cancer drug Neulasta (pegfilgrastim).

Fulphila, which secured approval to reduce the duration of febrile neutropenia in patients treated with chemotherapy in certain types of cancer, has been co-developed by Mylan and Biocon.

It is claimed to be the first FDA-approved biosimilar to Neulasta and is the second biosimilar from Mylan and Biocon's joint portfolio approved in the US.

Neulasta is a prescription medication used to help reduce infection due to a low white blood cell count, in people with certain types of cancer, who receive anti-cancer medicines that can cause fever and low blood cell count.

Mylan CEO Heather Bresch said: "I couldn't be prouder of this approval for Fulphila, the first alternative option for pegfilgrastim approved in the U.S., as it represents an important milestone for patients and further demonstrates Mylan's continued fight to expand access to medicine.”

The approval was based on a package of analytical, nonclinical and clinical data, which demonstrated that the product is similar to Neulasta.

The data showed that there were no clinically meaningful differences between the biosimilar product and Neulasta in terms of safety, purity and potency, said Mylan.

FDA commissioner Scott Gottlieb said: “Bringing new biosimilars to patients is a top priority for the FDA, and a key part of our efforts to help promote competition that can reduce drug costs and promote access.”

Mylan and Biocon are working on a range of biosimilar and insulin products, and the biosimilar to Neulasta is one of 11 biologic and insulin products co-developed by the firms.

As per terms of the deal, Mylan will exclusively commercialize Fulphila in the US, Canada, Japan, Australia and  New Zealand, as well as the European Union and European Free Trade Association countries.

Biocon has co-exclusive commercialization rights with Mylan for the product in the remaining countries of the world.