Sandoz Progresses $1 Billion Biomanufacturing Plan for BiosimilarsBy
Sandoz, a Novartis division, plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020 and invest $1 billion as part of a 2010-2020 investment scheme in biomanufacturing facilities in Schaftenau and Kundl, Austria.The five launches will be enabled by a regulatory submissions strategy of 11 filings over a three-year period (2015-2017).
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 $43.6 billion in 2015 global sales. Sandoz has already announced six of the 11 planned filings in the last 12 months with the most recent being European Medicines Agency (EMA) file acceptance of biosimilar rituximab in May 2016. Biosimilar rituximab is part of Sandoz' growing oncology and immunology portfolios. The oncology portfolio includes two marketed products (filgrastim and epoetin-alfa) and biosimilar candidate pegfilgrastim, which is under regulatory review in the US and European Union. Sandoz' early-stage pipeline has additional assets in oncology as well as other specialty therapeutic areas with plans to start new programs every year.
Biosimilars form a significant part of Sandoz' biopharmaceutical business which had 2015 sales of $772 million.