Express Pharma

US FDA approves Mylan and Biocon’s Fulphila

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Fulphila has been approved to reduce the duration of febrile neutropenia in patients treated with chemotherapy in certain types of cancer

Mylan and Biocon announced that the US Food and Drug Administration (US FDA) has approved Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon. Fulphila 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.

The approval for Fulphila comes as a good news for Mylan. Recently, the US FDA cited  issues with Mylan’s approval application for copies of insulin glargine, a type-1  diabetes drug  sold  as ‘Lantus’ by Sanofi. The regulatory authority, in its complete response letter (CRL),  sought clarifications from Mylan and Biocon about their move to change the manufacturing site for glargine from Bengaluru to a Malaysian facility.

 

 

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