Sandoz demonstrates strategic focus on China, with first-of-a-kind generic approval under Quality Consistency Evaluation system

May 09, 2019
  • Sandoz receives generic approval for Rosuvastatin from China's National Medical Products Administration (NMPA) under Quality Consistency Evaluation (QCE) system
  • Generic approval under China's recently introduced QCE system is first of a kind for multinational pharmaceutical company
  • Regulatory milestone demonstrates long-term strategic focus on pioneering access to high-quality medicines in world's largest, and rapidly-growing, generics market

Holzkirchen, Germany, May 9, 2019 - Sandoz today announced that it has received regulatory approval from China's National Medical Products Administration (NMPA) for its generic Rosuvastatin, under the NMPA's Quality Consistency Evaluation (QCE) system.

Sandoz is the first multinational pharmaceutical company to receive such an approval under the recently introduced QCE system, which aims to ensure that all generic medicines marketed (or manufactured) in China meet internationally recognized quality standards.

The QCE regulations are part of a wide-ranging package of healthcare system reforms introduced by the Chinese government over the past few years, which also offer the potential to accelerate national generic registration timelines significantly.

"This first-of-a-kind generic approval for a multinational company demonstrates our strategic focus on pioneering access to high-quality medicines in China, which is the world's largest generics market and offers enormous future potential to address unmet needs, particularly in the area of chronic diseases," said Francesco Balestrieri, ad interim CEO, Sandoz.

He added: "Specifically, this regulatory milestone helps to pave the way for Sandoz to compete in future generic tenders in China, as the evolving tender system increasingly moves to favor QCE-approved molecules. We see great potential to grow long-term in China and have the commitment and capabilities to succeed, including programs to conduct R&D and clinical development in China, specifically for the Chinese market."

Sandoz aims to continue submitting new generics applications in China, with a particular focus on areas of greatest unmet need, with the goal of further expanding access to its existing global portfolio of high-quality generic and biosimilar medicines.

Rosuvastatin belongs to a group of medicines known as statins, which reduce the risk of heart disease and help prevent strokes and heart attacks.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "investigational," "pipeline," "launch," "pioneering," "focus," "portfolio," "commitment," "purpose," "aims," "goal," "growing," "may,"  or similar terms, or by express or implied discussions regarding potential launches, marketing authorizations, new indications or labeling for generic rosuvastatin and the other generic products described in this press release, or regarding potential future revenues from such products. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. There is no guarantee that generic rosuvastatin and the other generic products described in this press release will be successfully launched in the expected time frame, or at all. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional competing versions of generic rosuvastatin and such other products; our ability to obtain or maintain proprietary intellectual property protection; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from marketing its products; general political, economic and industry conditions; safety, quality or production issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, 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, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars and a pioneer in the emerging field of prescription digital therapeutics. Our purpose is to pioneer access to healthcare by developing and commercializing novel, affordable approaches that address unmet medical need. Our broad portfolio of high-quality medicines, covering all major therapeutic areas and increasingly focused on value-adding differentiated medicines, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area.
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