FDA Rebukes Amgen Over Misleading Branding Of Neulasta
FDA Rebukes Amgen Over Misleading Branding Of Neulasta
The FDA has issued an untitled letter toAmgen Inc(NASDAQ: AMGN) for the misbranding of its blockbuster bone marrow stimulant, Neulasta (pegfilgrastim) injection.Amgen released a promotional communication that makes false or misleading claims and representations about the benefit of Neulasta when administered through the Onpro on-body injector compared to a prefilled syringe (PFS).Amgen used an unvalidated algorithm with unknown performance characteristics and the fact that the study was not balanced or controlled for potential bias, the FDA notes.And while Amgen does note two limitations to the study, the agency adds that the mentions do not mitigate the misleading claims and presentations in the banner.“The above misleading claims and presentations are concerning because they could undermine confidence not just in Neulasta delivered via PFS but also in FDA-licensed biosimilar pegfilgrastim products, which are only delivered via PFS,” the FDA said.Neulasta is the reference product for all FDA-licensed biosimilar pegfilgrastim products, which are only available as a prefilled syringe.Amgen has already been impacted by competition from biosimilars. Q1 2021 Neulasta fell 21% Y/Y to 2 million, as its average U.S. price slipped 30% Y/Y and 9% sequentially.Price Action:AMGN shares are up 0.50% at $245.93 during the market session on the last check Thursday.
FDA已經發布了一封無標題的信給安進公司(納斯達克股票代碼：AMGN)為其轟動一時的骨髓興奮劑Neulasta(Pegfilgrtim)注射貼錯品牌。Amgen發佈了一份促銷信息，與預填充注射器(PFS)相比，通過Onpro體內注射器注射Neulasta的益處做出了虛假或誤導性的聲明和陳述。FDA指出，Amgen使用了一種未經驗證的算法，其性能特徵未知，而且該研究沒有平衡或控制潛在的偏倚。該機構補充説，這些提法並沒有減輕橫幅上的誤導性聲明和表述。FDA表示：“上述誤導性聲明和表述令人擔憂，因為它們不僅可能削弱人們對通過PFS交付的Neulasta的信心，而且還會削弱人們對FDA許可的生物相似pegfilgrtim產品的信心，這些產品只能通過PFS交付。Neulasta是所有FDA許可的生物相似pegfilgrtim產品的參考產品，這些產品只能作為預灌裝注射器供應。安進已經受到來自生物製藥的競爭的影響。”2021年第一季度Neulasta同比下降21%，至200萬美元，其美國平均價格同比下降30%，環比下降9%。價格行動：在週四尾盤交易時段，amgn股價上漲0.50%，至245.93美元。
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