Amgen confirms FDA accepted Biologics License Application for ABP 938

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In their Q3 Earnings call, Amgen confirmed The United States Food and Drug Administration (FDA) accepted the Biologics License Application for ABP 938.¹

ABP 938 is an investigational biosimilar to EYLEA (aflibercept), which is a vascular endothelial growth factor receptor (VEGFR) Fc fusion protein, while a BLA is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.

Previously, Amgen had urged a deferral judge to unseal documents in Regeneron Pharmaceutical’s patent-infringement suit over Viatris proposed biosimilar version of EYLEA. The company stated the public has a right to access filings including “potentially dispositive allegations” that the patents are unenforceable.

Amgen finished conducting a Phase 3 trial on ABP 938 (NCT04270747) earlier this year, in which subjects were randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 or aflibercept administered by intravitreal injection.²

Amgen’s study, which involved 576 patients with wet AMD and wrapped up at the beginning of this year, and the company stated results “confirmed no clinically meaningful differences in efficacy, safety, and immunogenicity” compared with Eylea.²

Regulatory exclusivity for 2mg Eylea expires on 17 May 2024, allowing for biosimilar approvals thereafter.

References:

1. AMGEN REPORTS THIRD QUARTER FINANCIAL RESULTS. Press Release. Released October 31, 2023. Accessed November 6, 2023. https://investors.amgen.com/news-releases/news-release-details/amgen-reports-third-quarter-financial-results

2. AMGEN REPORTS SECOND QUARTER FINANCIAL RESULTS. Press release. Released August 3, 2023. Accessed November 6, 2023. https://www.prnewswire.com/news-releases/amgen-reports-second-quarter-financial-results-301893066.html