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还“怼”生物类似药吗?FDA局长发推批评原研厂商

医药魔方 医药魔方 来源:医药魔方
2019-01-12
生物制品
原文


“FDA将继续关注原研药厂商对生物类似药'恶意诽谤'的事件,特别是原研企业'有意混淆'生物类似药的安全性和有效性。如果发现哪家企业故意误导公众,我们将采取行动。”(截图来自FDA局长的推文)


近日,《华盛顿邮报》发表的一篇文章称,卫生保健和政府官员越来越担心,原研厂商为了保护利润以各种“恐吓”阻止患者选择仿制药。这不仅导致患者将陷入原研与仿制药的“保护争夺战”中,同时对国家控制医保支出增添了成本。


文章中所说的仿制药,主要是指从活细胞中培育出来的生物类似药。尽管FDA已经证明获批的药物都是安全有效的,但是一些原研企业通过对医生的“教育”,让医生对这些价格更便宜的“仿制”药品产生了怀疑。


FDA局长Scott Gottlieb接受采访时坦言,“我担心品牌公司有意或无意地努力制造关于无品牌生物药物安全性和有效性的混淆,特别是对那些考虑“原研替代”的患者和医生进行混淆和吓唬,这些信息可能会以不真实的方式破坏消费者对生物类似药的信心。”


Gottlieb没有透露具体公司或团体的名称。但针对一些高利润的创新药物生产商联盟发出的一些有关生物类似药警告。譬如“它们可能带来额外的风险”,“可能会把你送进ICU”,“潜在的问题涉及疗效与安全”等字眼,Gottlieb表示,如果FDA未向这些类似药厂商发出警告信,仅仅是原研故意误导公众的话,FDA将采取行动。


Gottlieb之所以愿意这么做,有分析称主要亦是从控费角度考虑。数据显示:未来10年内,美国医疗保健支出将从540亿美元增加到2000亿美元,而控制生物制剂的成本对于压缩美国医疗保健支出至关重要。


据估计,2010年至2015年间,美国处方药成本增长的70%来自生物制剂,而AbbVie的Humira等药物一路领先。根据非盈利组织Rand Corp.的一项研究,预计这些类似药的价格将降低10%至51%。


尽管生物类似药在欧洲上市多年,且大幅降低了欧洲消费者的成本。但在美国,无品牌的生物类似药仍然相对较新。欧洲药品管理局已经批准了40多种生物类似药。据FDA官方网站报道,FDA于2015年批准第一个生物类似药后,截止目前仅批准16个产品。



FDA通过分析其结构和审查来自人体测试的数据来批准生物类似药,并明确表示获批产品在安全性、纯度和效力方面与原研药没有临床意义上的差异。


“生物类似药与化学仿制药不同。生物药是在发酵罐里培养出的蛋白质,而不是简单化学物质的组合。生物药的复杂性,使得厂商很难做到原研的复制品,培养过程中多少会产生微小变化……”。原研厂商类似的说教,让人们对有效性或安全性产生怀疑。


一些游说者的理由还包括,“生物类似药可能会破坏你的治疗连续性,可能导致你进入急诊室,住院甚至是ICU,都可能会加剧或者引发你其他的疾病,使用生物类似药可能产生与原研不同的效果……”。


对生物类似药持有批判态度的以行业协会美国生物技术创新组织(BIO)为主,该协会每年花费超过1000万美元游说联邦政府;其次就是两家美国最大的生物药企业。这三家机构是非营利性组织“生物药安全联盟”(Alliance for Safe Biologic Medicines)的财政支持者,该组织旨在遏制无品牌的生物类似药的传播。


《华盛顿邮报》称,该联盟常见的方式就是打苦情戏,提醒医学界应该小心谨慎地将患者从原研药品过渡到生物类似药,以避免类似“沙利度胺”事件的发生。然而目前在美国或欧洲,使用生物类似药,并没有任何此类健康影响的建议。


去年夏天,辉瑞向FDA递交了一份文件指责安进、基因泰克和杨森生物在“替代性”问题上误导了医生和患者。辉瑞于2015年收购了生物类似药生产商Hospira。


混乱的信息加上混乱的改革运动已经进行了多年,随着市场竞争更接近现实,也因此吸引了更多关注。曾为生物类似药厂商提供咨询服务的Dana-Farber癌症研究所肿瘤学家Corey Cutler表示,生物制剂原研的营销人员在线下对仿制厂商攻击得更猛烈些,即便是FDA和生物类似药厂商对此也束手无策。

机器翻译

"The FDA will continue to pay attention to the incidents of original research drug manufacturers' malicious defamation of biosimilar drugs, especially the safety and efficacy of original research companies' 'intentional confusion' of biosimilar drugs.We will take action if we discover which company deliberately misleads the public."(Screenshot from FDA Secretary's tweet)

Recently, an article published in the Washington Post stated that health care and government officials are increasingly worried that the original research companies have used various" intimidation "to prevent patients from choosing generic drugs in order to protect profits.This will not only lead to patients will fall into the original research and generic drugs "protection battle", while adding to the cost of state control of health insurance expenditures.

The generic drugs mentioned in the article mainly refer to biosimilar drugs cultivated from living cells.Although the FDA has proven that approved drugs are safe and effective, some original research companies have "educated" doctors to make doctors suspicious of these cheaper "imitation" drugs.

Scott Gottlieb, FDA Director, admitted in an interview, "I am concerned that brand companies are deliberately or unintentionally trying to create confusion about the safety and efficacy of unbranded biopharmaceuticals, especially for patients and physicians who are considering" original research alternatives, "and this information may undermine consumers' confidence in biosimilar drugs in unreal ways."

Gottlieb did not disclose the name of the specific company or group.But there are some warnings about biosimilars from some highly profitable innovative drug manufacturers.For example, "they may pose additional risks," "may send you to the ICU," and "potential problems involve efficacy and safety," Gottlieb said that if the FDA did not issue a warning letter to these similar drug manufacturers, only the original research intentionally misled the public, the FDA will take action.

Gottlieb is willing to do so, there are analysis that mainly from the point of view of control fees.Data show that in the next 10 years, US health care spending will increase from 54 billion US dollars to 200 billion US dollars, and controlling the cost of biological agents is crucial to compress US health care spending.

It is estimated that between 2010 and 2015, 70% of the increase in prescription drug costs in the United States came from biologics, while drugs such as Humira of AbbVie led the way.According to the non-profit organization Rand Corp.In a study, it is expected that the price of these similar drugs will be reduced by 10% to 51%.

Despite the fact that biosimilar drugs have been available in Europe for many years and have drastically reduced the cost to consumers in Europe.But in the US, unbranded biosimilars are still relatively new.The European Medicines Agency has approved more than 40 biosimilar drugs.According to the FDA official website, after the FDA approved the first biosimilar in 2015, only 16 products have been approved so far.

FDA approves biosimilar drugs by analyzing their structure and reviewing data from human testing, and clearly states that there is no clinically significant difference in safety, purity, and potency between approved products and original research drugs.

"Biosimilars are different from chemical generics.Biopharmaceuticals are proteins grown in a fermenter, not a combination of simple chemicals.The complexity of biopharmaceuticals makes it difficult for manufacturers to reproduce the original research, and little changes will occur during the cultivation process... ".Similar preaching by the original research firm has raised doubts about effectiveness or safety.

Some lobbyists' reasons also include, "Biosimilar drugs may disrupt your continuity of treatment and may cause you to enter the emergency room, be hospitalized, or even the ICU, may exacerbate or cause your other illnesses, and the use of biosimilar drugs may have different effects than the original study …".

The industry association BIO, which is critical of biosimilar drugs, spends more than $10 million a year lobbying the federal government; followed by the two largest US biopharmaceutical companies.The three agencies are financial supporters of the Alliance for Safe Biologic Medicines, a non-profit organization that aims to curb the spread of unbranded biosimilars.

The Washington Post stated that the common way of the alliance is to play bitter drama, reminding the medical community that patients should be carefully and carefully transitioned from original research drugs to biosimilar drugs to avoid the occurrence of similar "thalidomide" events.However, there are currently no recommendations for the use of biosimilar drugs in the United States or Europe for any such health effects.

Last summer, Pfizer submitted a document to the FDA accusing Amgen, Genentech and Janssen Bio of misleading doctors and patients on "alternative" issues.Pfizer acquired biosimilar drug manufacturer Hospira in 2015.

The messy message coupled with the chaotic reform movement has been going on for many years, and as the market competition is closer to reality, it has therefore attracted more attention.Corey Cutler, an oncologist at the Dana-Farber Cancer Institute who has consulted biosimilar drug manufacturers, said that marketers of biologics have attacked imitation manufacturers more aggressively online, even if FDA and biosimilar drug manufacturers are helpless.

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