Dive Brief:

潜水简介：

The Food and Drug Administration is reviewing Alvotech’s newest application for its Humira biosimilar, setting a Feb. 24 deadline to decide on approval, the company said Wednesday. The regulator has twice rejected the drug because of manufacturing issues at an Iceland plant.

美国食品和药物管理局正在审查Alvotech公司Humira生物仿制药的最新申请，并于2月24日确定批准的最后期限，该公司周三表示。由于冰岛工厂的制造问题，监管机构两次拒绝了这种药物。

Alvotech said its latest approval application contains additional information on the methods used to measure quality and consistency at that plant to “address manufacturing facility deficiencies identified earlier by the FDA.”

Alvotech表示，其最新的批准申请包含有关用于衡量该工厂质量和一致性的方法的更多信息，以“解决FDA早些时候发现的制造工厂缺陷”

If the decision is positive, the Iceland-based drugmaker will be more than a year behind the first U.S. Humira biosimilar launched by Amgen and seven months behind a wave that hit the market at mid-year. Alvotech had been banking on its product being one of the first “interchangeable” Humira biosimilars — meaning it can be substituted by pharmacists — although that advantage could diminish by the time it launches..

如果这个决定是积极的，那么位于冰岛的药品制造商将比安进推出的第一批美国Humira生物仿制药落后一年多，并且在年中冲击市场的浪潮之后七个月。Alvotech一直致力于将其产品作为首批“可互换的”Humira生物仿制药之一-这意味着它可以被药剂师取代-尽管这种优势在推出时可能会减少。。

Dive Insight:

潜水洞察力：

The expiration of AbbVie’s key patents on Humira earlier this year has led to a rush of biosimilar makers hoping to grab a share of the $18.6 billion in U.S. sales it recorded last year. Alvotech, which is partnered with generics giant Teva, was in the running for a slice of that revenue until regulatory hurdles got in the way, exacerbated by the FDA’s inability to complete plant inspections during the COVID-19 pandemic..

今年早些时候，AbbVie在Humira上的主要专利到期，导致生物仿制药制造商急于占据去年美国销售额186亿美元的份额。与仿制药巨人Teva合作的Alvotech正在寻求一小部分收入，直到监管障碍到位，由于FDA在COVID-19大流行期间无法完成工厂检查而加剧。。

The initial setback came a year ago, when the FDA first identified manufacturing deficiencies. At the time, Alvotech said it intended to resolve the problems by December 2022, by which time a separate approval application seeking “interchangeability” was supposed to have a verdict from the FDA.

最初的挫折发生在一年前，当时FDA首次发现制造缺陷。当时，Alvotech表示打算在2022年12月之前解决这些问题，到那时，寻求“可互换性”的单独批准申请应该得到FDA的裁决。

In April, the FDA again rejected Alvotech's main approval application, based on deficiencies it spotted during a March inspection. And for good measure, it also knocked down the company's second attempt at an interchangeability approval just before it had the legal right to launch its biosimilar on July 1..

4月份，FDA再次拒绝了Alvotech的主要批准申请，因为它在3月份的检查中发现了不足之处。在7月1日发布生物仿制药的合法权利之前，它也打倒了公司第二次获得可互换性批准的尝试。。

Missing out on that revenue stream meant Alvotech needed to raise money. It would go on to bring in $140 million from Teva and other investors and other investors while also stepping up its involvement in getting the Iceland plant FDA-compliant.

错过这条收入来源意味着Alvotech需要筹集资金。它将继续从梯瓦和其他投资者以及其他投资者那里筹集1.4亿美元，同时也加强参与使冰岛工厂FDA合规。

Alvotech is leaning heavily on its possible status as the only high-concentration interchangeable Humira biosimilar. Boehringer has won interchangeability status for its low-concentration drug named Cyltezo and Pfizer could earn the same status for its low-concentration biosimilar, called Abrilada, by the end of the year..

作为唯一的高浓度可互换Humira生物仿制药，Alvotech正严重依赖其可能的地位。勃林格因其名为Cyltezo的低浓度药物而赢得了可互换性地位，到年底，辉瑞公司的低浓度生物仿制药Abrilada可以获得同样的地位。。

In the meantime, big pharmacy benefit managers have already made deals with other biosimilar makers, increasing Alvotech’s entry challenges. Cigna Healthcare’s Express Scripts and United Healthcare’s Optum have chosen Cyltezo, Amgen’s Amjevita and Novartis’ Hyrimoz, along with an unbranded Novartis biosimilar..

与此同时，大型药房福利经理已经与其他生物仿制药制造商达成协议，增加了Alvotech的入门挑战。Cigna Healthcare的Express Scripts和United Healthcare的Optum选择了Cyltezo，Amgen的Amjevita和诺华的Hyrimoz，以及无品牌的诺华生物仿制药。。

CVS Health, meanwhile, has chosen a private label version of Hyrimoz and has also announced its intention to become more deeply involved in biosimilar commercialization.

与此同时，CVS Health选择了Hyrimoz的私人标签版本，并宣布打算更深入地参与生物仿制药商业化。