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Sandoz ramps up biosimilar strategy

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Sandoz biosimilar manufacturing

To fuel its biosimilar expansion, Sandoz has earmarked more than $1 billion to bolster its biomanufacturing capabilities.

HOLZKIRCHEN, Germany — Sandoz aims to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020.

The Novartis division said Monday that the new biosimilars will emerge from “an aggressive regulatory submissions strategy” of 11 product filings that began last year and will run through 2017.

Plans also call for an investment of more than $1 billion, covering the period of 2010 to 2020, in state-of-the-art biomanufacturing facilities in Schaftenau and Kundl, Austria, which Sandoz said will enable the company to deliver biosimilar medicines to patients and health care providers worldwide on an “unprecedented scale.”

Sandoz reported that the launches, depending on regulatory requirements and approvals, will include biosimilars of Enbrel (etanercept), Humira (adalimumab), Neulasta (pegfilgrastim), Remicade (infliximab) and and Rituxan (rituximab). Combined, these biologics generated totaled sales of about $43.6 billion globally in 2015.

Six of the 11 planned filings have been announced in the last 12 months, most recently the European Medicines Agency’s filing acceptance of rituximab in May, according to Sandoz. The company added that its early-stage pipeline has more assets in oncology plus other specialty therapeutic areas, with plans to start new programs each year.

“Despite the impressive medical advances of the past century, access to medicines remains the single largest unmet health care need in developed and developing countries alike,” Richard Francis, division head and chief executive officer of Sandoz, told media at the Innovating For Patients Sandoz Biosimilars Day in Schaftenau. “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.”

Sandoz noted that it launched the world’s first biosimilar, Omnitrope in the European Union in 2006), which the company followed with Japan’s first biosimilar (Somatropin BS S.C.) in 2009 and the first U.S. biosimilar (Zarxio) in 2015 under the Food and Drug Administration’s new regulatory pathway.

These three biosimilar products have continued to see double-digit growth and form a significant part of Sandoz’s biopharmaceutical business, which had 2015 sales of $772 million, according to the company.


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