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 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鈥檚 decision comes after review of analytical, non-clinical and clinical data. The findings revealed that fulphila鈥檚 safety, purity and potency were mostly similar to neulasta.
Mylan president Rajiv Malik said: 鈥淭oday鈥檚 approval of fulphila represents a meaningful step forward in the affordability and accessibility of cancer care in the US.
鈥淚t also is yet another confirmation of Mylan鈥檚 deep scientific, clinical, regulatory and intellectual property capabilities, which are widely recognised in the industry and bolster Mylan鈥檚 reputation聽as a partner of choice in the global effort to bring complex medicines to market.鈥�
To be launched over the coming weeks, Fulphila is the second biosimilar in the partners鈥� joint portfolio to secure the FDA approval.
US Tariffs are shifting - will you react or anticipate?
Don鈥檛 let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataTheir ogivri was approved in 2017 as a biosimilar to herceptin聽to treat HER2-overexpressing breast and metastatic stomach cancers.
Biocon CEO & joint managing director Dr. Arun Chandavarkar said: 鈥淭his important milestone comes soon after our achievement of being the first to receive US FDA approval for biosimilar to herceptin.
鈥淭his approval expands our oncology portfolio for the benefit of cancer patients and supports our mission to improve access to high quality, affordable biopharmaceuticals globally.鈥�
