Another example of domestic manufacturing policy trumping the public health?
It took only two months after patent expiry in China for two generic versions of Novartis AG’s blockbuster chronic myeloid leukemia drug Glivec (imatinib) (marketed as Gleevec in the U.S.) to gain China FDA approval, and many more are expected to follow suit. But Novartis plans to fight back by highlighting the quality and efficacy of its brand and its long-running patient assistance program.
Two companies received CFDA approval June 26, Jiangsu Hansoh Pharmaceutical Co. Ltd. and Jiangsu Chia-tai Tianqing Pharmaceutical Co. Ltd., or CTTQ, 60% of which is held by Hong Kong-listed Sino Biopharmaceutical Ltd. CTTQ holds the first capsule generic approval, while Hansoh received CFDA approval for a tablet formulation of imatinib. Generic imatinib for chronic myeloid leukemia will launch in August, Sino Biopharmaceutical said during a July 4 event.
Although the Glivec compound patent expired in China in April, Novartis still holds a beta crystalline patent in the country until 2018 and a patent for a gastrointestinal stromal tumors indication until 2021, Novartis China said. According to Novartis, the two China generics are likely alpha crystalline forms of imatinib.
“The generic has a different crystal type, so the product quality and treatment result will be totally different,” said Wendy Wang, head of communications for Novartis Oncology China.
The imatinib generics race is just warming up. According to CFDA’s database, as of July 16, there were 16 new applications for imatinib generics in 2013, including an imported drug application.
