Progress on biosimilar pipeline paves way for five planned launches by 2020
Sandoz now plans a total of 11 biosimilar filings by end 2017 (EU and US) and has already delivered on six
Investments of more than USD 1 billion in state of-the-art biomanufacturing facilities, backed by industry-leading capabilities as part of Novartis, positions Sandoz to deliver biosimilars at unprecedented scale
Holzkirchen, June 20, 2016 - Sandoz, a Novartis Division and the global leader in biosimilars, 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.
Building on decades of experience Sandoz has a strong first mover advantage having launched the world’s first biosimilar (Omnitrope® in the EU, 2006), the first biosimilar in Japan (Somatropin BS S.C., 2009) and the first biosimilar approved under the new regulatory pathway in the US (Zarxio®, 2015). It has significantly grown its biosimilar business and continues to deliver double-digit growth for its three in-market medicines. Biosimilars form a significant part of Sandoz’ biopharmaceutical business which had 2015 sales of USD 772 million. Sandoz’ future biosimilar offerings are expected to see it expand further in oncology and enter the immunology space – two therapy areas where its products are set to benefit from being part of a broader Novartis portfolio.
USD 1 billion earmarked for capacity expansion program in Austria Sandoz, which started developing and manufacturing biologics in 1980, has built industry-leading capabilities in biopharmaceutical development and production. Over the period of 2010 to 2020, capital expenditures of USD 1 billion have been earmarked for expanding the state-of-the-art biomanufacturing facilities required to supply the growing patient base benefitting from Sandoz biosimilars and Novartis novel biological drugs. As part of the Novartis Group, Sandoz has access to deep therapeutic area capabilities in clinical development and commercialization as well as manufacturing know-how, helping to deliver on its pipeline assets.
Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as “plans,” “planned,” “positions,” “aiming,” “opportunity,” “will,” “expected,” “committed,” “pipeline,” “set,” “earmarked,” or similar terms, or by express or implied discussions regarding potential marketing approvals for any of the products in the Sandoz biosimilar pipeline, or regarding potential future revenues from such biosimilar products. Such forward-looking statements reflect the current views of the Group regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results expressed or implied by such statements. There can be no guarantee that any of the products in the Sandoz biosimilar pipeline will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that, if approved, such products will be approved for all indications included in their respective reference product labels. Neither can there be any guarantee that any such biosimilar products will be commercially successful in the future. In particular, management’s expectations regarding the products in the Sandoz biosimilar portfolio could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; competition in general; global trends toward health care cost containment, including government, industry and general public pricing pressures; unexpected litigation outcomes; unexpected manufacturing, quality or safety issues; general economic and industry conditions, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Sandoz Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high- quality medicine. Our portfolio of more than 1,000 molecules, covering all major therapeutic areas, accounted for 2015 sales of USD 10.1 billion. In 2015, our products reached more than 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.