Case study on the substitution of Eheng for Losartan

Source: emeda 2016-7-5 research brief this study demonstrates the substitutability of domestic innovative drugs for imported drugs from clinical application, pharmacoeconomics, market performance and other dimensions through comparative analysis between domestic innovative drugs or generic drugs and original research drugs, so as to promote the independent research and development, innovation and market access of Chinese drugs Put forward policy suggestions for the reform of relevant policies, so that China's innovative drugs can play a real role of substitution In terms of variety selection, two generic drugs and two domestic innovative drugs with the same pharmacological effects as their original research or imported products are selected to analyze from four directions: quality consistency, real world sales performance, market access cases and pharmacoeconomics, and analyze the substitutability of domestic drugs for imported drugs, as well as the health resources that can be saved by using domestic drugs Benefit of the domestic sick population The analysis drug in this report is oxaliplatin The comparison product is the product overview and characteristics of the original research product "losadine" and the domestic product "aiheng" Oxaliplatin was researched and developed by debiopharm company in Switzerland, manufactured and sold by Sanofi company in France It was first listed in France in 1996, approved to be imported into China in 1999, and approved by FDA in 2002 It is approved to be mainly used in the second-line treatment of metastatic colorectal cancer, or in combination with 5-fluorouracil (5-FU) and folic acid (LV) (FOLFOX program) for the first-line treatment of advanced colorectal cancer Currently, it is a class B medicine for medical insurance in China The U.S patent for the drug compound expired in 2013, but oxaliplatin has no compound patent, crystal patent or administrative protection in China In 2000, Jiangsu Hengrui Pharmaceutical Co., Ltd took the lead in developing oxaliplatin API and lyophilized powder, and obtained new drug certificate and production approval It was the four kinds of new drugs at that time, listed under the trade name of "aiheng" Aiheng (oxaliplatin for injection) is suitable for patients with colorectal cancer metastasis after failure of fluorouracil treatment It can be used alone or in combination with fluorouracil When used alone or in combination, the recommended dose is 130 mg / m2 once according to the body surface area, and 250-500 ml 5% glucose solution is added for infusion for 2-6 hours Once every 3 weeks (21 days) when there is no major toxicity The adjustment of dose is based on the safety, especially the safety of Neurology Eheng was approved for listing in the European Union and the United States in 2012 and 2014, respectively 3 The consistency of quality and efficacy between aiheng and losartan oxaliplatin for injection of Jiangsu Hengrui Pharmaceutical Co., Ltd the trade name "aiheng" was approved by the EU and FDA in August 2012 and June 2014 respectively, and was included in the FDA Orange Book (the drug catalog approved through equivalence evaluation) According to the opinions of the general office of the State Council on the evaluation of the quality and efficacy of generic drugs issued by the State Council on March 5, 2016 -“ For generic drugs that have been approved for listing in the European Union, the United States and Japan by domestic drug manufacturers, they can apply for listing in accordance with the new registration classification of chemicals based on the relevant information of foreign registration declaration, and the drugs approved for listing shall be deemed to pass the consistency evaluation; the drugs produced and listed in the same production line in China and approved for listing in the European Union, the United States and Japan shall be deemed to pass the consistency evaluation Sexual evaluation " Therefore, it can be concluded that aiheng and losadine have the same quality and efficacy Figure 1 approval of Jiangsu Hengrui oxaliplatin by FDA: 4 Real world sales performance of Eheng and losartan A after the expiration of losartan's patent in the United States, the market of oxaliplatin was rapidly replaced by generic drugs According to IMS data, the original drug of losartan Sanofi in the United States market was in 2012 The annual sales before the expiration of the annual patent amounted to US $1.1 billion, and by 2014, the sales of original research drugs was only US $06 million, while that of generic drugs was US $84 million In 2014, Jiangsu Hengrui oxaliplatin for injection (aiheng) passed the US FDA and EU quality certification price of $70, and received orders of $20 million in less than two months after its listing Figure 2 sales of oxaliplatin in the United States before and after the expiration of the patent (US $100 million) B unlike the United States, losartan still has a large market share in China In 2014, the amount of oxaliplatin used in the National Hospital was 1716.21 million yuan, and the national sales in the first three quarters of 2015 reached 1279.15 million yuan, with an average growth rate of 2.29% in three years 。 Lesaden's share of sales volume in hospitals in China is very small, but the share of money is still large In the bidding policies of some regions, the differentiated treatment of original research drugs and generic drugs leads to the failure of excellent domestic generic drugs to win the bid in some regions, which leads to the increase of lesaden's share instead of decrease Figure 3 amount of drug used by oxaliplatin production enterprises in national hospitals in 2012-2015q3 (10000 yuan) Figure 4 amount of drug used by oxaliplatin production enterprises in national hospitals in 2012-2014 (10000 tablets) less than 10% of loxadine used accounted for 40% For the above amount share, most domestic enterprises have a large difference in product quantity and amount proportion, and the enterprises with low price policy occupy more market shares of domestic enterprises Table 1 drug amount share of oxaliplatin production enterprises in national hospitals 2012-2015q3 enterprise name 2012 2013 2015q3 amount Share quantity share amount share quantity share amount share quantity share amount share quantity share Jiangsu Hengrui Pharmaceutical Co., Ltd (aiheng) 42.97% 60.59%, 39.16%, 57.48%, 35.82%, 54.07%, 35.12%, 53.81%, 31.59%, 5.66%, 35.05%, 5.79%, 40.08%, 6.76%, 42.86% 7.18% Other domestic enterprises 25.44% 33.74% 25.79% 36.72% 24.11% 39.16% 22.02% 39.01% total 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% C due to the influence of some policies, AI Heng's sales share in Guangdong Province decreased sharply From January to November 2015, according to the analysis of oxaliplatin in China's provinces, the share distribution in Guangdong Province is more representative, AI Heng's quantity share is only 0.88%, and from 2012-2015 The market share of Guangdong declined rapidly in, and the analysis of the reasons for the change of Guangdong's market share has a lot to do with the market access policies of the province Table 2 sales volume share of oxaliplatin from January to November 2015: Sanofi (lesaden) Jiangsu Hengrui Pharmaceutical Co., Ltd in top 10 provinces Other domestic enterprises (aiheng): Jiangsu 4.85%, 70.24%, 24.91%, Shandong 2.83%, 54.45%, 42.72%, Zhejiang 14.63%, 71.46%, 13.91%, Shanghai 9.89% 62.23%, 27.88%, Henan 0.81%, 40.42%, 58.77%, Guangdong 26.28%, 0.88%, 72.84%, Hebei 0.80%, 41.48%, 57.72%, Beijing 34.74% 52.36% 12.90% Sichuan 3.69% 59.85% 36.46% Liaoning 3.27% 45.40% 51.34% Table 3 sales volume share change of oxaliplatin in some provinces from 2012 to November 2015 Provincial enterprises 2012 2013 2015 (1-11) other domestic enterprises in Jiangsu 26.55% 27.38% 24.61% 24.91% Sanofi 3.50% 3.30% 3.95% 4.85% Jiangsu Hengrui pharmaceutical Limited by Share Ltd (Ai Heng) 69.95% 69.31% 71.44% 70.24% other domestic enterprises in Shandong 44.36% 47.22% 44.73% 42.72% Sanofi (lesaden) 2.44% 2.00% 2.37% 2.83% Jiangsu Hengrui Pharmaceutical Co., Ltd (aiheng) 53.20% 50.78% 52.90% 54.45% other domestic enterprises in Shanghai 31.10% 27.67%, 27.59%, 27.88%, Sanofi 6.71%, 8.02%, 8.99%, 9.89%, Jiangsu Hengrui Pharmaceutical Co., Ltd (aiheng) 62.19%, 64.32%, 63.42%, 62.23% Zhejiang Other domestic enterprises 9.92%, 10.40%, 11.65%, 13.91%, Sanofi 12.34%, 12.59%, 14.46%, 14.63%, Jiangsu Hengrui Pharmaceutical Co., Ltd (aiheng) 77.74%, 77.02% 73.89% 71.46%