Indian drugmakers Mylan and Biocon announced yesterday the US Food and Drug Administration (FDA) has accepted to review their proposed version of Amgen’s Neulasta (pegfilgrastim).
The submission is the second biosimilar in their collaborative pipeline to be accepted for review in as many months, after a version of Roche’s Herceptin (trastuzumab) was submitted in November and subsequently acknowledged by the Agency.
The FDA decision date is October 9, and if approved it will be the first Neulasta biosimilar in the US.
Novartis offshoot Sandoz had its Neulasta biosimilar rejected last July by the FDA which asked for additional data in a complete response letter, but according to a spokesperson Biocon is confident in the quality of its regulatory filing.
“We have already filed in EU and have followed it up with our filing in the US,” Biopharma-Reporter was told.
The proposed pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global market. Under terms of the deal, Biocon will make the products from its biomanufacturing facilities in Bangalore, India.
“From a capacity perspective, we are well-placed to cater to our mid-term demand in both emerging and developed markets,” the spokesperson told us.
“A meaningful capacity expansion for our monoclonal antibodies and other proteins will be needed in order to meet peak global demand requirements for our portfolio of products. We will trigger expansion in line with our projected capacity requirements.”
The site has seen a number of expansions over the past few years. The latest, the firm said in its annual report, is a $25m second fill-finish line to support future biologics growth set to be validated this year.