China rolls out copycat target list to boost generic development


2019-06-24 18:10:00 FiercePharma


The U.S. FDA compiles a list of off-patent drugs without an approved generic to encourage the development of copycats. Now, the Chinese authorities are rolling out a similar initiative, only with some extra incentives. On Thursday, China’s National Health Commission published (Chinese) its first proposed list of 34 drugs (full list below) that the agency says are already off patent or nearing patent expiration but have no generic drug application in the country or lack competition. The plan is to invite drugmakers to make copies—and here comes the key—under drug regulator’s priority review pathway, which was until now mostly given to innovative drugs. The list covers originators from many foreign pharmas, including Pfizer, AstraZeneca, Merck & Co., Johnson & Johnson, Roche, Bristol-Myers Squibb, Takeda, Eli Lilly, and more. And the drugs span a wide range of therapeutic areas, including HIV, anti-infectives, ophthalmology, cancer, blood and immune disorders, etc. Some prominent names can be found on the list. Teva’s multiple sclerosis blockbuster Copaxone, which just saw its first U.S. copycat from Mylan less than two years ago, is probably the best-selling drug on the list by global sales. Johnson & Johnson subsidiary Actelion’s pulmonary artery hypertension drug Tracleer and United Therapeutics' rival med Remodulin are both included. Roche’s CMV retinitis treatment Valcyte and chemotherapies Faslodex and Ixempra from AZ and BMS, respectively, are also among those listed. China made certain of its intention to make that list in January. At that time, it said the government would update the list at the end of each year starting from 2020. And key small molecules and biologics on the list will also be incorporated into state-backed R&D plans. The initiative is seen as another push by the Chinese government to bring in competition to rein in drug costs. In a recent decree, physicians are strictly not allowed to write brand names on prescriptions, and even if they do, pharmacists could fill them with generics. Multinational firms have for a long time enjoyed strong sales from their older medicines in China, even as they suffer in developed markets like the U.S. and EU. But in a bulk procurement program being piloted in 11 major cities, these foreign bigwigs have started to feel the heat. With the scheme, drugmakers—originator and generic—bid for big supply contracts with all public hospitals in those cities. Of the final 25 contracts, foreign pharmas only won two. Pfizer, which lost out to domestic makers with Lipitor, and AstraZeneca, which failed in its attempt at winning the Crestor tender, are both guiding slower China sales growth this year. For the current 34-drug list, the Chinese government is opening up for public comments for five work days. Full list of the 34 drugs by generic name: abacavir, alcaftadine, atovaquone, azathioprine, bosentan, brivaracetam, colesevelam hydrochloride, cyclophosphamide, dapsone, deferasirox, dofetilide, eletriptan, ertapenem, fezoterodinum, formoterol fumarate, fosaprepitant, fulvestrant, glatiramer, icatibant, ixabepilone, levodopa/benserazide, levothyroxine, mercaptopurine, methotrexate, nitisinone, posaconazole, pyridostigmine, raloxifene, rilpivirine, tafluprost, tretinoin, treprostinil, valganciclovir, vigabatrin. Editor's Note: The story has been updated to clarify that the priority review designation was previously not only given to innovative drugs. For example, a Rituxan biosimilar by Fosun Henlius was recently approved in China after being put under priority review.
美国食品和药物管理局( FDA )编制了一份未获批准仿制药的非专利药品清单,以鼓励仿制药的发展。如今,中国政府也推出了类似的举措,只是出台了一些额外的激励措施。 周四,中国国家卫生委员会( National Health Commission )公布了首份34种药品的拟议名单(完整名单如下),该机构表示,这些药品已经申请专利或即将到期,但在中国没有仿制药申请或缺乏竞争。该计划将邀请制药商在药品监管机构的优先审评路径下复制——这是关键——迄今为止,该路径主要用于创新药物。 该名单涵盖了许多外国制药公司的发起人,包括辉瑞(Pfizer)、阿斯利康(AstraZeneca)、默克(Merck)、强生、罗氏(Roche)、百时美施贵宝、武田(Takeda)、礼来(Eli Lilly)等。而这些药物涵盖了广泛的治疗领域,包括艾滋病毒、抗感染药物、眼科、癌症、血液和免疫疾病等。 一些著名的名字可以在名单上找到。 梯瓦(Teva)的多发性硬化症重磅炸弹 Copaxone 可能是全球销量最好的药物。该公司在不到两年前刚刚从迈兰(Mylan)看到了第一个美国仿制药。强生子公司爱可泰隆(Actelion)的肺动脉高压药物 Traceleer 和联合治疗公司的竞争对手 medRemodulin 都包括在内。罗氏(Roche)公司的 CMV 视网膜炎治疗 Valcell 和化疗 Faslodex 和 Ixempra 分别来自 AZ 和百时美施贵宝(BMS),也被列出。 中国明确表示打算在明年1月公布这一名单。当时,中国政府表示,从2020年开始,中国政府将在每年年底更新这份名单。此外,名单上的关键小分子和生物制剂也将纳入国家支持的研发计划。 这一举措被视为中国政府为控制药品成本而引入竞争的又一项举措。在最近的一项法令中,医生被严格禁止在处方上写品牌名称,即使他们这样做,药剂师也可以给他们添加仿制药。 长期以来,跨国企业在中国的老年药品销售强劲,尽管它们在美国和欧盟等发达市场受到影响。但在11个主要城市试行的大宗采购计划中,这些外国大公司已开始感受到了压力。通过该计划,制药商——发起人和非专利药——与这些城市的所有公立医院签订了大型供应合同。在最后25份合同中,外国制药公司只赢得了两份。 辉瑞( Pfizer )和阿斯利康( AstraZeneca )都在引领今年中国销售增长放缓。辉瑞在立普妥( Lipitor )和阿斯利康( AstraZeneca )两家国内制造商中输给了它们。 对于目前的34种药品目录,中国政府将开放公众评论五个工作日。 按通用名列出的34种药物的完整清单: abacavir , alkatadine , atovaquone , azathioprine , bostonen , brivaraceam , colesevelam 盐酸盐,环磷酰胺,氨苯砜, edrasirox , dofetilide , eletritan , ertapinem , fezoterodinum , formoterol furante , glatiramer , icatibant , ixiabropine , levodopa / benserazide , levoothyrxine , merspotoflu , methotrexate , sinine , posaconazole ,吡多西他啶、雷洛昔芬、利吡韦林、他氟普罗、曲维汀、曲比林、缬更昔洛韦、维加巴坦。 编辑的注意:这个故事已经被更新,以澄清优先审评指定之前不仅给予创新药物。例如,复星亨利( Fosun Henlius )的 Rituxan 生物生物仿制药物在被优先审查后最近在中国获得批准。