Dive Brief:

潜水简介：

Alvotech and Teva on Tuesday won Food and Drug Administration approval for Selarsdi, the second biosimilar poised to challenge Johnson & Johnson’s blockbuster psoriasis drug, Stelara.

周二，Alvotech和Teva获得了食品和药物管理局对Selarsdi的批准，Selarsdi是第二种生物仿制药，有望挑战强生公司的重磅银屑病药物Stelara。

The FDA cleared Selarsdi for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children who are at least 6 years old. The companies said they expect to begin selling the medicine on or after Feb. 21, 2025, a delayed introduction due to a legal settlement with J&J..

FDA批准Selarsdi用于治疗6岁以上成人和儿童的中度至重度斑块状银屑病和活动性银屑病关节炎。这些公司表示，他们预计将于2025年2月21日或之后开始销售该药，由于与强生达成法律和解，该药推迟上市。。

The two companies are likely to enter the market after Amgen, which won approval for an interchangeable biosimilar called Wezlana in October. Amgen is also subject to a legal settlement, and the company has said its product will launch no later than Jan. 1, 2025.

这两家公司很可能在安进（Amgen）于10月获得一种名为Wezlana的可互换生物仿制药的批准后进入市场。安进也受到法律和解的约束，该公司表示其产品最迟将于2025年1月1日上市。

Dive Insight:

潜水洞察：

Stelara is one of many top-selling medicines that will face competition from copycat versions this decade, including a large number of biologic drugs.

Stelara是许多畅销药物之一，这些药物将在本十年内面临模仿版本的竞争，其中包括大量生物药物。

AbbVie’s anti-inflammatory medicine Humira — sales of which topped $21 billion in 2022 — has been a top target for biosimilars, with 10 copycat versions cleared by the FDA. One of those medicines is Alvotech and Teva’s Simlandi, which won approval in February along with interchangeable status, which means pharmacists can directly substitute the drug for Humira..

AbbVie的抗炎药Humira（2022年销售额超过210亿美元）一直是生物仿制药的首要目标，FDA批准了10种仿制药。其中一种药物是Alvotech和Teva的Simlandi，该药物于2月获得批准，并具有可互换性，这意味着药剂师可以直接用该药物替代Humira。。

So far, Humira has hung onto much of its market share, with AbbVie deploying rebates to preserve placement on insurers’ coverage lists. Likely reflecting that, global revenue from Humira dropped to $14.4 billion in 2023. Doctors may also be reluctant to switch patients from a name brand that’s working..

到目前为止，Humira仍保持着大部分市场份额，AbbVie部署了回扣，以保持其在保险公司承保名单上的位置。2023年，Humira的全球收入降至144亿美元，这很可能反映了这一点。医生可能也不愿意让病人改换一个有效的名牌。。

J&J faces less of an onslaught for Stelara, with just two biosimilars approved to date and both facing delayed launches. Still, the company is already seeing sales flatten out for Stelara in part due to slipping market share in psoriasis and psoriatic arthritis. And copycat versions will lead to price declines, Jessica Moore, head of investor relations, told analysts on a conference call Tuesday..

强生对Stelara的冲击较小，迄今为止只有两种生物仿制药获得批准，而且都面临推迟发射的问题。尽管如此，该公司已经看到Stelara的销售额持平，部分原因是牛皮癣和牛皮癣关节炎的市场份额下降。投资者关系主管杰西卡·摩尔（JessicaMoore）周二在一次电话会议上告诉分析师，抄袭版本将导致价格下跌。。

Selarsdi and Simlandi are the first two biosimilars to emerge from a strategic partnership between Alvotech and Teva originally inked in 2020 and expanded in 2023. Teva will be responsible for marketing Selarsdi in the U.S.

Selarsdi和Simlandi是Alvotech和Teva战略合作伙伴关系中产生的首批两种生物仿制药，最初于2020年签署，并于2023年扩大。Teva将负责在美国营销Selarsdi。