Biocon and its partner Mylan said they had got USFDA approval for Fulphila or Pegfilgrastim. Pegfilgrastim is a biosimilar version of Amgen’s Neulasta used to stimulate the level of neutrophils, a type of white blood cell that gets damaged in cancer patients undergoing chemotherapy. Neulasta had US sales of USD 4.2 billion for the 12 months ending March 31, 2018, according to IQVIA. Biocon-Mylan’s Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the US. The duo got the approval of breast cancer drug Trastuzumab last year. Biocon said its partner Mylan anticipates launch of Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. “It’s a moment of great pride to be the first to receive approval for a biosimilar pegfilgrastim by the USFDA,” said Arun Chandavarkar, Biocon CEO and Joint Managing Director.
“This important milestone comes soon after our achievement of being the first to receive USFDA approval for biosimilar trastuzumab. It represents a further endorsement of the Biocon-Mylan partnership’s ability to successfully develop complex molecules to exacting quality and regulatory standards,” Chandavarkar added. Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Neulasta is one of 11 biologic and insulin products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world. While Biocon develops and manufactures the drug, Mylan takes care of regulatory approvals and marketing. Moneycontrol had earlier reported that US FDA found purely procedural observations in its product approval inspection (PAI) of the Bengaluru facility. The approval for Fulphila was based on a comprehensive package of analytical, non-clinical 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.
Biosimilars involve clinically testing the drug on animals and humans to demonstrate that the drug is highly similar to the innovator biological product (known as a reference product) and has no clinically meaningful differences in terms of safety and effectiveness from it. Biosimilar medicines are deemed by FDA to be highly similar to an already-approved biologic product. They fill an urgent and unmet need for more affordable alternatives to biologic therapies, increasing access and providing savings for patients and the overall healthcare system. It is projected that biosimilars will generate savings of USD 54 billion in direct spending on biologic drugs in the US between 2017 and 2026.
Source : moneycontrol
Published on: September 26, 2018