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由于政府鼓励医生开仿制药，跨国制药公司正在失去在中国的市场份额。仿制药与品牌药的药性相同，但许多人担心它们在疗效或安全性上有差异。病人发现更难获得品牌药物，即使他们能够负担得起价格。
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政府正试图通过国家大宗采购计划来降低药品成本，该计划已进入第五个年头，并将更多的非专利药品列入该计划的批准名单。面对市场份额的萎缩和销售的下滑，一些跨国制药公司正在改变其战略，更加专注于新药的研究和开发。
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这使得一些品牌药物在中国更加稀缺，许多病人被开出的非专利药物取代。尽管活性成分相同，但许多人担心仿制药在疗效或安全性方面存在差异，导致人们对不可靠的药品感到担忧。
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Xeloda在中国的市场份额从2019年的70%以上急剧下降到2022年上半年的15.9%，原因是2020年国家大宗采购计划引入了两种被选中的仿制药。
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批量采购计划导致品牌药的市场份额从28.9%下降到12.7%，而所选仿制药的国家采购份额从27.1%上升到80%以上。
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政府鼓励医院优先使用集中采购的药品，如果医疗机构开出未选定的药品，则要求其提供解释。诸如默克夏普公司的Singulair、辉瑞公司的Medrol以及阿斯利康、赛诺菲和诺华公司开发的抗肿瘤药物等常用药物都难以获得处方。
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中国在2012年开始讨论仿制药一致性评价体系的计划，该体系在2016年正式开展。全国政协科技发展中心2022年的一项调查显示，超过五分之一的受访者认为通过批量购买计划采购的药品不可靠。像浙江的何文这样的患者表示，他们在服用原版和仿制版时感受到切实的差异。同一研究还发现，超过84%的受访者认为原版和仿制版之间存在差异，而临床疗效和安全性是他们最关心的问题。
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2021年国家医疗保障局的一项研究，涵盖了超过11万名患者的数据，显示通过批量购买计划选择的14种药物与原版相比，在疗效和安全性方面没有明显差异。根据该研究，在该计划开始之前和之后，报告的不良反应案例的比率也没有明显变化。总部设在北京的首都医科大学医疗保险研究所的价格和采购主任蒋昌松说，个别案例不能否定整个仿制药行业的疗效。
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上海卫生发展研究中心部门主任陈敏兴说，国家采购政策的目的是为患者降低药价，节省医保费用，同时推广国产药品，但需要一个长期的控制系统来监督仿制药的生产和流通。所有被考虑纳入大宗购买计划的仿制药必须已经通过了国家对质量和疗效与品牌原药的等效测试。
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跨国制药公司发现，由于人口众多，中国是一个有吸引力的市场。然而，北京的中央采购政策导致一些公司改变了他们的战略，还有一些公司退出了市场。在2018年至2022年的七个采购批次中，294个主要类别中只有45个品牌药物被选中。
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以价换量的策略并不总是能带来销售增长，在某些情况下还会产生相反的效果。德国制药公司拜耳在2020年第二季度看到其来自Glucobay的销售收入下降超过73.8%。面对市场份额被侵蚀、价格压力增加和专利到期的挑战，许多制药公司已经缩减、拆分或剥离其品牌药物业务。
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2021年，罗氏将Xeloda在中国大陆的营销权授予了青岛百合医药有限公司，因为该药的全球销售量在2020年下降了25.8%。德国制药商Cheplapharm后来收购了Xeloda的相关业务，目的是确保Xeloda继续为中国的所有患者提供。
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Multinational pharmaceutical companies are losing market share in China as the government encourages doctors to prescribe generic drugs. Generic drugs are the same medication as the brand name drugs, but many people worry they differ in efficacy or safety. Patients are finding it harder to get branded drugs, even if they can afford the pricetag.
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The government is trying to drive down medicine cost through a national bulk-buying program, which is in its fifth year and adding more generic drugs to the list of those approved for the scheme. Facing shrinking market share and slumping sales, some multinational pharmaceutical companies are changing their strategy to focus more on research and development of new medicines.
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This has made some brand name drugs even more scarce in China, with many patients being prescribed generic drugs instead. Despite the same active ingredient, many people worry generic drugs differ in efficacy or safety, leading to fears of unreliable medicines.
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Xeloda’s market share in China fell drastically from over 70% in 2019 to 15.9% in the first half of 2022 due to the introduction of two generic drugs that were selected for the state’s bulk-buying scheme in 2020.
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The bulk-buying scheme caused the market share for branded drugs to drop to 12.7% from 28.9%, while the chosen generic versions’ national purchase share rose to over 80% from 27.1%.
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Hospitals are encouraged to prioritize the centrally procured drugs, and medical institutions are asked to provide an explanation if they prescribe unselected drugs. Commonly used drugs such as Merck Sharp & Dohme’s Singulair, Pfizer’s Medrol, and anti-tumor drugs developed by AstraZeneca, Sanofi, and Novartis are having difficulty getting prescribed.
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China began discussing plans for a consistency evaluation system for generic drugs in 2012, with the system officially carried out in 2016. A 2022 survey by the Science and Technology Development Center of the CPA showed that more than one fifth of the respondents thought medicine procured through a bulk-buying scheme was not reliable. Patients like He Wen of Zhejiang have said they feel tangible differences when taking original and generic versions. The same study also found more than 84% of the respondents think there is a difference between original and generic versions, with clinical efficacy and safety being their top concerns.
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A 2021 study from the National Healthcare Security Administration, covering data from over 110,000 patients, showed that 14 of the selected drugs through the bulk-buying scheme had no significant difference in efficacy and safety compared to the original. There was also no significant change in the rate of adverse reaction cases reported before and after the scheme began, according to the study. Individual cases cannot discredit the efficacy of the entire generic drug industry, said Jiang Changsong, the director of price and procurement at Beijing-based Capital Medical University’s medical insurance research institute.
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The purpose of the national procurement policy is to reduce the price of medicine for patients and save health insurance costs while promoting domestic drugs, but a long-term control system to supervise the generic drugs’ production and circulation is needed, said Chen Minxing, a department director at the Shanghai Health Development Research Center. All generics being considered for the bulk-buying scheme must have already passed the country’s equivalency test for quality and efficacy compared to the branded original.
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Multinational pharmaceutical firms have found China to be an attractive market due to its large population. However, Beijing’s central procurement policy has led to some firms changing their strategies and others exiting the market. Only 45 brand name drugs were selected out of 294 major categories in seven procurement batches from 2018 to 2022.
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Price for volume strategy does not always lead to sales growth and in some cases has had the opposite effect. German pharmaceutical firm Bayer saw its sales revenue from Glucobay drop more than 73.8% in the second quarter of 2020. Facing challenges of eroding market share, increasing price pressure and patent expiration, many pharmaceutical companies have scaled back, split or divested their brand name drug business.
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In 2021, Roche granted the marketing rights in the Chinese mainland for Xeloda to Qingdao Baheal Medical Co Ltd after the pill’s global sales volume fell 25.8% in 2020. German drugmaker Cheplapharm later acquired Xeloda-related business, with the goal of ensuring the continued availability of Xeloda for all patients in China.