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Humira丧钟敲响:印度仿制药商Cadila推出全球Humira仿制药

  1. Eemptia
  2. Humira
  3. 生物仿制药
  4. 阿达木单抗

来源:生物谷 2014-12-10 09:49

Humira(阿达木单抗)是全球最畅销的药物,年销售超过百亿美元。近日,印度Cadila推出全球首个Humira生物仿制药Exemptia,标志着Humira丧钟已敲响!!

2014年12月10日讯 /生物谷BIOON/ --单抗生物制品堪称药品市场的一座金矿。近年来,随着大批单抗品牌药面临专利悬崖,生物仿制药正呈现井喷式增长,全球已掀起了生物药仿制热潮。继上周美国仿制药商Epirus与印度合作伙伴兰伯西(Ranbaxy)在印度推出首个类克(Remicade)生物仿制药Infimab。本周,印度另一家仿制药商Cadila Healthcare宣布在印度推出全球首个Humira(修美乐)生物仿制药Exemptia。(相关阅读:挖矿生物仿制药:Epirus联合兰伯西在印度推出Remicade生物仿制药

Humira由艾伯维(AbbVie)研发,该药是全球最畅销的药物,位列《2013年最畅销的25个药物》榜单之首,年销售额超过百亿美元。根据艾伯维发布的数据,Humira在2014年第三季度的销售额达到32.6亿美元,占到了艾伯维总收入的65%。Humira美国专利将于2016年下半年到期,欧洲专利将于2018年到期。尽管Humira工艺复杂,但诸多药企早已按捺不住纷纷开始仿制,包括制药巨头诺华和安进,双方各自开发的Humira生物仿制药已处于III期临床,并已取得重要进展。

Humira在美国售价为1000美元/瓶,而Cadila计划将印度市场Exemptia的售价定为品牌药的五分之一(即200美元/瓶)。然而,有分析师认为,印度有超过70%的人口生活消费水平低于2美元/天,同时该国医疗保险稀缺,即便Exemptia仅售200美元/瓶,但对大多数印度民众而言仍高不可攀。

Cadila预计,Exemptia在印度市场的销售额将达到1600万-3200万美元,该药将用于治疗炎症性疾病,如类风湿性关节炎、青少年特发性关节炎、银屑病关节炎和强直性关节炎,在印度这类患者群体大约为1200万例。Cadila同时指出,计划2015年会晤美国和欧洲的监管机构,并预计在2019年在美国推出Exemptia。

未来5年,将有数个最畅销的重磅生物药失去专利保护。根据路透社BioWorld,到2020年生物仿制药市场将达到250亿美元。在全球范围内,有数百家药企正在竞相开发生物仿制药,包括印度仿制药商雷迪博士(Dr Reddy)、西普拉(Cipla)和鲁宾制药(Lupin)。

英文原文:India's Cadila launches first cheaper copy of world's top-selling drug

MUMBAI, Dec 9 (Reuters) - Indian drugmaker Cadila Healthcare Ltd said on Tuesday it launched in India the first biosimilar version of the anti-inflammatory medicine adalimumab, the world's top-selling drug, at a fifth of its U.S. price.

The drug's branded version is sold under the name Humira by U.S. firm AbbVie Inc, and costs $1,000 for a vial in the United States. Humira had sales of $3.26 billion in the quarter ended September, accounting for 65 percent of AbbVie's total revenue.

A price of $200 a vial would still keep the drug out of reach for most people in India, where more than 70 percent of the population lives on less than $2 a day and health insurance is scarce.

Biosimilars are cheaper copies of biotech drugs - medicines made from proteins and other large molecules.

Cadila expects sales of between 1 billion rupees ($16.16 million) and 2 billion rupees from its biosimilar of Humira in the Indian market, Deputy Managing Director Sharvil Patel told Reuters.

The company will launch its version under the name Exemptia for treating diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis.

About 12 million people in India suffer from these disorders, Cadila said in a statement.

"We are working towards being among the first wave of the launch of this drug's biosimilars globally," Patel said, adding he does not expect any domestic competition on the drug "in short term."

The company expects to launch the medicine in the United States in 2019, he said.

Humira's U.S. patent will expire in late 2016 and AbbVie has said it will take years for other drugmakers to develop and win approval for their own generic versions.

Cadila has meetings scheduled with the U.S. and Europe regulators next year, Patel said. "It's a very attractive market, there are many, many companies working on this product."

Biosimilars are expected to account for about one quarter of the $100 billion worth of sales stemming from off-patent biological drugs by the end of the decade, a study compiled by Thomson Reuters BioWorld said in September.

Several hundred companies around the world are chasing the biosimilars market, including Indian generic drugmakers Dr Reddy's Laboratories Ltd, Cipla Ltd and Lupin Ltd.

($1 = 61.8800 Indian rupees) (Reporting by Zeba Siddiqui in Mumbai; Editing by Sumeet Chatterjee and Anupama Dwivedi)

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