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Pictured: Boehringer Ingelheim office in California/iStock, Sundry Photography
图片:加州勃林格殷格翰办事处/伊斯托克,桑德里摄影
Boehringer Ingelheim on Monday unveiled lower wholesale pricing for its adalimumab-adbm injection, the company’s interchangeable biosimilar to AbbVie’s blockbuster chronic inflammatory therapy Humira (adalimumab).
Boehringer Ingelheim周一公布了其阿达木单抗adbm注射剂的较低批发价格,该公司可互换的生物仿制药与AbbVie的重磅炸弹慢性炎症疗法Humira(阿达木单抗)。
At its wholesale acquisition cost, adalimumab-adbm is now priced at an 81% discount to Humira. Boehringer Ingelheim also launched a branded version of the biosimilar in July 2023, bearing the brand name Cyltezo with a 5% discount versus Humira.
以其批发收购成本,阿达木单抗adbm现在定价为Humira的81%折扣。勃林格殷格翰还于2023年7月推出了生物仿制药的品牌版本,品牌名称为Cyltezo,与Humira相比折扣5%。
This “dual pricing approach” will help the adalimumab biosimilar contribute to the sustainability of the healthcare system, as well as “improve access to Adalimumab-adbm and help meet the varied needs of people with a variety of chronic inflammatory diseases,” Stephen Pagnotta, executive director and biosimilar commercial lead at Boehringer Ingelheim, said in a statement..
这种“双重定价方法”将有助于阿达木单抗生物仿制药促进医疗保健系统的可持续性,以及“改善阿达木单抗adbm的获取并帮助满足各种慢性炎症性疾病患者的各种需求”,Stephen Pagnotta,Boehringer Ingelheim的执行董事兼生物仿制药商业负责人在一份声明中说。。
According to adalimumab-adbm’s label, its interchangeability designation indicates that there are “no clinically meaningful differences” between it and the reference product. This designation poses more stringent requirements—including demonstrating in trials that using the biosimilar in place of its branded counterpart does not compromise safety and efficacy—but also provides better prescribing flexibility.
根据阿达木单抗adbm的标签,其可互换性名称表明它与参考产品之间“没有临床意义上的差异”。这个名称提出了更严格的要求,包括在试验中证明使用生物仿制药代替其品牌对应物不会损害安全性和有效性,但也提供了更好的处方灵活性。
Interchangeable products may be used in place of the reference medicine without needing to change the prescription..
可互换的产品可以用来代替参考药物,而不需要改变处方。。
First approved in 2002 for rheumatoid arthritis, Humira is a monoclonal antibody that binds to the TNF-alpha cytokine, a key player in the inflammatory cascade and driver of pathologic inflammation. The therapy has since been approved in several other indications, including Crohn’s disease, ulcerative colitis, hidradenitis suppurativa and ankylosing spondylitis..
Humira于2002年首次批准用于类风湿性关节炎,是一种与TNF-α细胞因子结合的单克隆抗体,TNF-α细胞因子是炎症级联反应和病理性炎症驱动因子的关键参与者。该疗法已被其他几种适应症批准,包括克罗恩病,溃疡性结肠炎,化脓性汗腺炎和强直性脊柱炎。。
Humira has consistently been among AbbVie’s best-selling assets. In 2021, the blockbuster therapy made more than $20.6 billion in total, representing over 14% growth compared to the prior year. However, its loss of exclusivity and the threat of biosimilar competition have eroded Humira’s market footing and eaten away at its sales figures.
Humira一直是AbbVie最畅销的资产之一。2021年,重磅炸弹疗法总计超过206亿美元,与去年相比增长了14%以上。然而,它的排他性丧失和生物仿制药竞争的威胁已经侵蚀了Humira的市场基础,并削弱了其销售数据。
In 2022, the antibody’s revenues dropped by 22.2% in international markets..
2022年,抗体在国际市场的收入下降了22.2%。。
This downward trend in sales has only gotten worse this year. In the second quarter of 2023, Humira’s total revenue was 25.5% lower than during the same period the previous year.
今年销售的下降趋势只会变得更糟。在2023年第二季度,Humira的总收入比去年同期低25.5%。
Aside from Boehringer Ingelheim, several other companies have also launched their Humira biosimilars. Leading the pack is Amgen, whose Amjevita hit the market in January 2023. Other offerings include those from Organon and partner Samsung Bioepis, Coherus Biosciences, Celltrion, and Sandoz.
除了勃林格殷格翰之外,其他几家公司也推出了Humira生物仿制药。领先的是Amgen,他的Amjevita于2023年1月进入市场。其他产品包括Organon和合作伙伴Samsung Bioepis,Coherus Biosciences,Celltrion和Sandoz的产品。
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
Tristan Manalac是位于菲律宾大马尼拉的独立科学作家。他可以联系到tristan@tristanmanalac.com或者tristan.manalac@biospace.com.