Mylan and Biocon have received the US FDA approval for Fulphila. The drug has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer.
 
Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the US. Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment.
 
The approval for Fulphila was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that the product is highly similar to Neulasta. The data demonstrated that there were no clinically meaningful differences between the biosimilar product and Neulasta in terms of safety, purity and potency.
 
Neulasta had US sales of $4.2 billion for the 12 months ending March 31, 2018, according to IQVIA.
 
“We are proud of this approval for Fulphila, the first alternative option for pegfilgrastim approved in the US as it represents an important milestone for patients, stated Heather Bresch, CEO, Mylan.

According to Rajiv Malik, president, Mylan the 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 the company’s scientific, clinical, regulatory and intellectual property capabilities.
 
Dr Arun Chandavarkar, CEO & joint managing director, Biocon said that the approval for a biosimilar pegfilgrastim by the US FDA is an important milestone. It represents a further endorsement of the Biocon-Mylan partnership’s ability to successfully develop complex molecules to exacting quality and regulatory standards.
 
“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,” he added.