The US Food and Drug Administration (FDA) has approved Mylan’s Fulphila (pegfilgrastim-jmdb) – co-developed with India-headquartered Biocon – to reduce the risk of infection in nonmyeloid cancer patients following chemotherapy.
The biosimilar’s successful approval is Mylan and Biocon’s second after Ogivri, a biosimilar to Roche’s Herceptin (trastuzumab), which was authorised for sale in the US late last year.
The Mylan/Biocon partnership was formed to develop and commercialise six biosimilar products. According to the collaboration agreement, Biocon is responsible for manufacturing the products at its facilities in Bangalore, India.
“It is a proud moment for both Biocon and Mylan to receive this second biosimilar approval in the US,” a Biocon spokesperson told us.
“It will enable us to pursue our path of making a difference to patient lives by providing access to high quality, more affordable biosimilars,” the spokesperson added.
However, Fulphila’s US approval was not without regulatory setbacks. In October last year, we reported the FDA had rejected the Neulasta candidate in response to CMC data issues observed at Biocon’s plant.
Earlier this week, a Mylan representative told us that Fulphila – expected to launch in the “coming weeks” – is awaiting regulatory review in other geographic locations: “Mylan has submissions pending in the European Union and several additional markets including Canada, Australia and several emerging markets.”
Development competition
A number of companies have invested in Neulasta biosimilar programmes over the past three years, but, with the exception of Mylan and Biocon, are yet to receive regulatory approval.
In July 2016, Sandoz, a Novartis company, received an FDA complete response letter (CRL) for its Neulasta biosimilar candidate and withdrew its EU-based Neulasta biosimilar application in early 2017.
In June 2017, the FDA vetoed Coherus’ biologics license application (BLA) for CHS-1701 – also a Neulasta biosimilar candidate – and earlier this year, Pfenex said it was actively looking for partners to reinitiate its Neulasta biosimilar programme.