Dapagliflozin

Amid an ongoing expansion of China’s volume-based procurement (VBP) scheme to lower drug costs, the Chinese government has singled out a fraud case involving a foreign originator drug in a warning to the industry. In an attempt to influence whether a drug gets selected for price bidding, a foreign drug innovator faked doctors’ signatures in a petition, China’s National Healthcare Security Administration (NHSA) said in a post (Chinese) on Tuesday. Among the 78 signatures from 31 hospitals, over 80% were found to be doctored. Some signatures were forged by sales representatives, some used misappropriated images from other sources, and some pointed to individuals that do not exist, according to the agency. As for the few signatures that the experts themselves indeed wrote, the doctors were mostly tricked into signing the document under the guise of survey questionnaires or post-sales follow-up, the agency said. The drug has since been included in the latest VBP batch of 65 drug varieties, which together represent a total market value of nearly 60 billion Chinese yuan ($8.8 billion), according to the NHSA. The VBP, now in its 12th round, is a government-led drug-buying program targeting off-patent medicines. Under the program, generics and the originators offer price cuts to secure procurement contracts with hospitals. The government unveiled the latest list on June 23 and is now in the bidding process. In a statement to local news outlet The Paper , Novartis confirmed it was not the unnamed drugmaker flagged in the NHSA alert. The Swiss pharma’s blockbuster heart failure treatment Entresto (sacubitril/valsartan) is one of the biggest products in this VBP round. According to local reports, Entresto and its generics generated more than 6 billion yuan of end-market sales ($880 million) at public hospitals in China last year, with the Novartis originator accounting for more than 90%. The VBP program now threatens to split up that huge market by rewarding significant shares to companies that offer lower prices. In what’s slated to be an über-competitive bidding process, more than 30 Entresto generics competitors are vying for a place under VBP, according to local drug intelligence database DXY Insight. As part of the largest patent expiry in Novartis’ history, Entresto lost its U.S. market exclusivity last year and has seen major sales declines since. Some uncertainties remain for VBP’s potential impact on Entresto. The Novartis drug is among eight products that carry an asterisk, which indicates ongoing patent disputes. A few days before the revelation of the latest VBP list last month, China’s National Intellectual Property Administration doled out a five-year patent-term extension to Entresto to make up for time lost during its drug regulatory review process, effectively pushing back the expiration of its core patent to November 2031. In a new rule introduced into VBP this time, generic rivals to those asterisked drugs must submit a declaration of non-infringement or be removed from procurement platforms. Takeda’s angiotensin II receptor blocker Edarbi (azilsartan medoxomil) and acid blocker Takecab (vonoprazan fumarate), Eli Lilly’s JAK inhibitor Olumiant, Daiichi Sankyo’s factor Xa inhibitor edoxaban and AstraZeneca’s Xigduo XR (dapagliflozin and metformin extended release) are also included in VBP despite ongoing patent disagreements. Takeda, Bayer and Eisai have also denied they were the company in the NHSA’s announcement, according to The Paper. Bayer’s drospirenone/ethinyl estradiol oral contraceptive, known commercially as Yaz or Yasmin, and its imaging contrast agent Ultravist (iopromide) are included for VBP bidding against generics. Eisai has anti-vertigo medication Merislon (betahistine) and anti-seizure med Fycompa (perampanel) on the list. In addition to the companies above, the 65-item roster includes brand-name products from almost all major pharmas, including Astellas, Fresenius Kabi, GSK, Johnson & Johnson, Pfizer, Merck & Co., Merck KGaA, Otsuka, Sanofi and Servier. Among the smaller firms involved are Cheplapharm, Dr. Falk Pharma and Grünenthal from Germany; Japan’s Maruishi Pharmaceutical, Sumitomo Pharma, LTL Pharma and Minophagen Pharmaceutical; as well as the Wellcome Foundation and Tillotts Pharma in Switzerland.