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Pending regulatory approval, Sandoz plans to release biosimilars to etanercept, adalimumab, pegfilgrastim, infliximab, and rituximab.
Sandoz announced on June 20, 2016 that it has plans to launch five biosimilars of major oncology and immunology biologics by 2020, the company said in a press announcement. Sandoz, a division of Novartis, is the maker of the first United States approved biosimilar, Zarxio (filgrastim-sndz), which was approved by FDA in March 2015. Zarxio, a biosimilar for Amgen’s Neupogen (filgrastim) was approved for all five of its reference product’s indications.
Pending regulatory approval, Sandoz says it plans on launching biosimilars to Enbrel (etanercept), Humira (adalimumab), Neulasta (pegfilgrastim), Remicade (infliximab), and Rituxan (rituximab). According to Sandoz, collectively, these biologics generated approximately $43.6 billion in global sales in 2015. The five launches will be enabled by a regulatory submissions strategy of 11 filings over a three-year period (2015-2017), the company noted in a press announcement. Sandoz said it also plans to invest $1 billion, between 2010 and 2020, in biomanufacturing facilities in Schaftenau and Kundl, Austria.
"Despite the impressive medical advances of the past century, access to medicines remains the single largest unmet healthcare need in developed and developing countries alike,” said Richard Francis, division head and CEO of Sandoz, at the Innovating for Patients, Sandoz Biosimilars Day in Schaftenau, Austria. “Biologics have revolutionized treatment of many disabling and life-threatening diseases, but far too many people who need these medicines are not able to access them. At Sandoz, we are committed to significantly broadening patient access to biologics with a series of major biosimilar launches over the next few years.”