Pictured: FDA's signage outside its office in Washington, DC/iStock, JHVEPhoto

图为美国食品和药物管理局（FDA）位于华盛顿特区（Washington，DC）/伊斯托克（iStock，JHVEPhoto）办公室外的标牌

The FDA on Tuesday approved Alvotech and Teva Pharmaceuticals’ Selarsdi (astekinumab-aekn), a biosimilar to Johnson & Johnson’s blockbuster immunotherapy Stelara (ustekinumab).

FDA周二批准了Alvotech和Teva Pharmaceuticals的Selarsdi（astekinumab aekn），这是强生公司的重磅免疫疗法Stelara（ustekinumab）的生物仿制药。

Like its branded reference product, Selarsdi is a subcutaneous injection that can be used to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis in pediatric and adult patients. Unlike Stelara, however, Selarsdi is not approved for Crohn’s disease and ulcerative colitis.

与品牌参考产品一样，Selarsdi是一种皮下注射，可用于治疗儿童和成人患者的中度至重度斑块状牛皮癣和活动性银屑病关节炎。然而，与Stelara不同，Selarsdi未被批准用于克罗恩病和溃疡性结肠炎。

Alvotech CEO Robert Wessman in a statement said that the companies are “delighted” about the approval of Selarsdi, which he insists will provide “a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contributed to the reduction of inflationary pressures in healthcare costs” once it hits the market in early 2025..

Alvotech首席执行官罗伯特·韦斯曼（RobertWessman）在一份声明中表示，公司对塞拉斯迪（Selarsdi）的批准感到“高兴”，他坚称，一旦塞拉斯迪（Selarsdi）于2025年初上市，它将“为改善患者获得炎症性疾病中重要生物制剂的机会提供重要机会，并有助于降低医疗保健成本的通货膨胀压力”。。

The FDA’s approval is based on analytical and clinical data from Teva and Alvotech’s development program, including the Phase III AVT04-GL-301 study which found that Selarsdi was just as effective and safe as Stelara in patients with moderate to severe chronic plaque-type psoriasis. The late-stage trial also found that Selarsdi had an equivalent immunogenicity profile to Stelara..

FDA的批准是基于Teva和Alvotech开发计划的分析和临床数据，包括III期AVT04-GL-301研究，该研究发现Selarsdi在中度至重度慢性斑块型银屑病患者中与Stelara一样有效和安全。后期试验还发现，Selarsdi具有与Stelara相当的免疫原性。。

The partners also submitted Phase I data demonstrating that the pharmacokinetic, safety, immunogenicity and tolerability profiles of the biosimilar was similar to that of the reference product.

合作伙伴还提交了第一阶段数据，证明生物仿制药的药代动力学，安全性，免疫原性和耐受性与参考产品相似。

Stelara’s active ingredient is ustekinumab, a human monoclonal antibody designed to target and selectively bind the IL-12 and IL-23 cytokines, both of which are important in the inflammatory and immune cascades. Its mechanism of action dampens the underlying pathologic mechanisms in various immune-mediated diseases..

Stelara的活性成分是ustekinumab，一种人类单克隆抗体，旨在靶向并选择性结合IL-12和IL-23细胞因子，这两种细胞因子在炎症和免疫级联反应中都很重要。其作用机制抑制了各种免疫介导疾病的潜在病理机制。。

The FDA first approved Stelara in 2009 for moderate-to-severe plaque psoriasis, and the biologic has since become one of J&J’s—and the industry’s—best-selling assets. In 2023, Stelara brought in nearly $10.9 billion, an 11.7% increase from its sales figure the prior year. At the same time, however, Stelara also had to contend with the expiration with one of its key patents..

FDA于2009年首次批准Stelara治疗中度至重度斑块状牛皮癣，该生物制剂已成为强生和业界最畅销的资产之一。2023年，Stelara的销售额接近109亿美元，比上一年的销售额增长了11.7%。然而，与此同时，斯特拉拉还不得不与一项关键专利的到期抗争。。

To stave off the biosimilar competition and to prolong its exclusivity, J&J has been striking a series of deals that would postpone the entry of these competitors in the U.S. market. In May 2023, the pharma reached an agreement with Amgen, which would allow the latter to market its biosimilar no later than January 1, 2025..

为了避免生物仿制药的竞争并延长其排他性，强生一直在达成一系列协议，推迟这些竞争对手进入美国市场。2023年5月，该制药公司与安进公司达成协议，允许安进公司在2025年1月1日之前销售其生物仿制药。。

Teva and Alvotech signed a similar settlement with J&J, postponing the entry of Selarsdi into the U.S. to no later than February 21, 2025.

Teva和Alvotech与强生签署了类似的和解协议，将Selarsdi进入美国的时间推迟到2025年2月21日。

Despite the strong performance of its cancer portfolio, J&J on Tuesday reported Stelara sales of $2.45 billion in the first quarter of 2024, falling short of Wall Street expectations of $2.6 billion.

尽管其癌症投资组合表现强劲，但强生周二报告称，2024年第一季度Stelara销售额为24.5亿美元，低于华尔街26亿美元的预期。

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

特里斯坦·马纳拉克（TristanManalac）是一位独立的科学作家，总部位于菲律宾马尼拉。在LinkedIn上联系他，或发电子邮件给他tristan@tristanmanalac.com或tristan.manalac@biospace.com.