The US Food and Drug Administration (FDA) has approved Biocon Ltd’s new facility at Bengaluru for the manufacturing of pegfilgrastim biosimilar Fulphila, the company said in a release today.
Approval for the new manufacturing facility for Fulphila in Bengaluru will help Biocon’s subsidiary Biocon Biologics and its partner Mylan to scale up capacity multi-fold so as to cater to the US and other global markets, the company said.
“This approval will help us better meet global patient needs for Fulphila, a high quality biosimilar Pegfilgrastim co-developed with Mylan and manufactured by Biocon Biologics,” the subsidiary’s chief executive officer Christiane Hamacher was quoted as saying in a release.
The US FDA’s approval was for Biocon and Mylan’s supplemental Biologics License Application (sBLA) for pegfilgrastim, which is a form of a protein that stimulates the growth of white blood cells and decreases the incidence of infection.
An sBLA is filed with the US FDA to seek certain modification for the original biologics application, like in this case, the addition of a new plant.
The US FDA conducted a pre-approval inspection of the new manufacturing facility from 10-19 September.
Biocon also produces pegfilgrastim biosimilar at another plant in Bengaluru.
Fulphila, co-developed by Biocon and Mylan, was the first biosimilar Pegfilgrastim to be approved in the US and was commercially launched in July 2018. It is also approved in other developed markets of European Union, Australia and Canada.