Mylan and Biocon have secured the US Food and Drug Administration’s (FDA) approval for their fulphila, which is a biosimilar to neulasta.
Jointly developed by the companies, fulphila is indicated to minimise the febrile neutropenia duration in certain cancer patients undergoing chemotherapy. Symptoms of febrile neutropenia include a fever, other signs of infection and low neutrophil count.
Fulphila is the first biosimilar to neulasta approved by the FDA. The regulator’s decision comes after review of analytical, non-clinical and clinical data. The findings revealed that fulphila’s safety, purity and potency were mostly similar to neulasta.
Mylan president Rajiv Malik said: “Today’s approval of fulphila represents a meaningful step forward in the affordability and accessibility of cancer care in the US.
“It also is yet another confirmation of Mylan’s deep scientific, clinical, regulatory and intellectual property capabilities, which are widely recognised in the industry and bolster Mylan’s reputation as a partner of choice in the global effort to bring complex medicines to market.”
To be launched over the coming weeks, Fulphila is the second biosimilar in the partners’ joint portfolio to secure the FDA approval.
Their ogivri was approved in 2017 as a biosimilar to herceptin to treat HER2-overexpressing breast and metastatic stomach cancers.
Biocon CEO & joint managing director Dr. Arun Chandavarkar said: “This important milestone comes soon after our achievement of being the first to receive US FDA approval for biosimilar to herceptin.
“This approval expands our oncology portfolio for the benefit of cancer patients and supports our mission to improve access to high quality, affordable biopharmaceuticals globally.”