Sandoz announces plans for five major global biosimilar launches by 2020

June 21, 2016 11:18 AM

Sandoz, a Novartis Division, plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020, aiming at broadening access to these treatments for more patients.

Biosimilars, which are clinically comparable to their reference biologics and introduced following loss of patent exclusivity, represent a significant opportunity for health care savings globally.

The five launches will be enabled by an aggressive regulatory submissions strategy of 11 filings over a three year period (2015-2017). Furthermore, plans to invest over USD 1 billion, between 2010 and 2020, in state-of-the-art biomanufacturing facilities in Schaftenau and Kundl, Austria are expected to ensure that Sandoz’ biosimilar medicines reach patients and healthcare professionals around the world.

“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, addressing journalists at the Innovating For Patients Sandoz Biosimilars Day in Schaftenau, Austria. Francis continued: “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.”

Subject to regulatory requirements and approvals, Sandoz’ upcoming launches will include biosimilars of Enbrel (etanercept), Humira (adalimumab), Neulasta (pegfilgrastim), Remicade (infliximab) and Rituxan (rituximab). Together these biologics generated approximately USD 43.6 billion in 2015 global sales. Sandoz has already announced six of the 11 planned filings in the last 12 months – the most recent being European Medicines Agency (EMA) file acceptance of biosimilar rituximab (May 2016). Sandoz’ early-stage pipeline has additional assets in oncology as well as other specialty therapeutic areas with plans to start new programs every year.

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