Sandoz is first multinational to secure generic approval under new Chinese guidelines

pharmafile | May 20, 2019 | News story | Sales and Marketing China, Novartis, Sandoz, generics, pharma, rosuvastatin 

Sandoz has revealed that its generic statin rosuvastatin, known in its branded incarnation as Crestor, has been given approval in China from the country’s National Medical Products Administration (NMPA). The therapy was indicated for the reduction of heart disease risk and prevention of stroke and heart attack.

The decision makes rosuvastatin the first drug in the nation approved from a multinational company under the newly-introduced Quality Consistency Evaluation (QCE) system, which designed to raise the bar of quality and safety for all drugs manufactured or marketed in China with internationally recognised quality standards.

Sandoz announced its intention to follow up this success with further generic drug submissions, particularly in areas of persistent unmet need.

“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,”commented Francesco Balestrieri, interim CEO at Sandoz. “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 favour QCE-approved molecules. We see great potential to grow long-term in China and have the commitment and capabilities to succeed, including programmes to conduct R&D and clinical development in China, specifically for the Chinese market.”

Matt Fellows

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