Mylan and Biocon announced the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Fulphila, a biosimilar to Amgen's Neulasta (pegfilgrastim).
The CHMP positive opinion is based upon a review of evidence demonstrating biosimilarity. Data submitted as part of the Marketing Authorization Application included similarity assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to the reference product, Neulasta. The Phase I program in healthy volunteers and Phase III clinical study conducted in breast cancer patients receiving adjuvant and neoadjuvant chemotherapy demonstrated no clinically meaningful differences in terms of pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity compared to Neulasta.
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The CHMP positive opinion will now be considered by the European Commission. The decision on approval is expected by November 2018.
Fulphila was approved by the U.S. Food and Drug Administration (FDA) earlier this year and is the first FDA-approved biosimilar for Neulasta in the U.S. Regulatory applications for Fulphila also have been submitted in Australia, New Zealand, Canada and several other countries.
"We are very proud to be a leader in bringing the first wave of biosimilars to the European market and driving greater access to more affordable treatment options for patients living with chronic and life-threatening illness such as cancer,” Mylan President Rajiv Malik said. “Receiving CHMP positive opinion for our pegfilgrastim biosimilar, Fulphila, is a key milestone in this journey, demonstrating our commitment to patient and healthcare communities across Europe and the strength of our collaboration with Biocon."
"CHMP's decision to recommend approval of Biocon and Mylan's biosimilar Pegfilgrastim brings us a step closer to offer this high quality, affordable biologic therapy for cancer patients in the EU, having launched this product in the US, earlier this year,” Biocon CEO & Joint Managing Director, Dr. Arun Chandavarkar, said. “It is an outcome of our commitment to enhance access for patients and be a leading global biosimilars player on the back of significant investments in R&D and global scale manufacturing, together with our partner Mylan."
Neulasta had brand sales of more than $450 million in Europe for the 12 months ending June 30, 2018, according to IQVIA.
Chemotherapy-induced febrile neutropenia (FN) causes treatment delays and interruptions and can have fatal consequences. Current guidelines provide recommendations on granulocyte colony-stimulating factors (G-CSF) for prevention of FN when the risk is considered to be high. Pegfilgrastim as an injectable biologic medication is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF). It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.