Eli Lilly Issues Cease-And-Desist Letters to Compounders Over Weight-Loss Drug Copies As Shortage Resolves
Eli Lilly Issues Cease-And-Desist Letters to Compounders Over Weight-Loss Drug Copies As Shortage Resolves
Eli Lilly And Co. (NYSE:LLY) is ramping up its legal campaign against the compounding companies temporarily allowed to make and sell copycat versions of its blockbuster drugs for weight loss until a U.S. shortage.
礼来（纽交所: LLY）正在加大对允许临时生产和销售其畅销药物减肥仿制药的配制公司的法律攻势。
Last week, the FDA determined the shortage of Eli Lilly tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved.
上周，FDA确定了礼来替利塞肽注射剂的短缺问题已得到解决。替利塞肽是一种胰高血糖素样肽-1（GLP-1）药物。
The U.S. health regulator reminded compounders of the legal restrictions on making copies of FDA-approved drugs. The update has sparked concern among medical professionals, patients, and drug compounding facilities.
美国卫生监管机构提醒复方制剂师不要制作FDA批准药物的复制品而受到法律限制。这一更新引起了医疗专业人员、患者和药物混合制剂厂的关注。
Also Read: Regeneron Chief Flags Health Risks with Popular Weight-Loss Medications Like Ozempic, Says Company Targets Muscle Preservation For Its Obesity Drugs.
此外阅读: Regeneron首席指出奥泽帕等受欢迎减肥药物存在健康风险，并表示公司以肌肉保留作为肥胖药物的目标。
Tirzepatide injection, branded as Mounjaro and Zepbound, has been in shortage since 2022 due to increased demand, allowing compounding pharmacies and outsourcing facilities to produce the drug and meet patient demand.
因2022年需求增加，曾因生产不足而短缺的蒂泽帕肽注射剂，商标为Mounjaro和Zepbound，现已得以生产，使混合制剂药房和外包设施能够生产该药以满足患者需求。
The compounding groups Outsourcing Facilities Association and FarmaKeio Custom Compounding filed a complaint alleging that removing the drug from the shortage list is based solely on the manufacturer's production capabilities.
配制集团外包设施协会和远卫睿自定义配制提出投诉，声称将该药从短缺清单中移除仅基于制造商的生产能力。
The FDA's decision to withdraw the drug without prior notice or public consultation has been criticized for depriving patients of essential care, potentially driving up drug prices, and favoring special interests.
FDA未经事先通知或公开磋商即决定撤回该药物的做法遭到批评，认为这将剥夺患者的基本护理，可能会推高药物价格，并偏袒特殊利益。
The Bloomberg report adds that the U.S. pharmaceutical giant has issued hundreds of cease-and-desist letters to telehealth companies, compounding pharmacies, and medical spas, demanding they halt the production, sale, and promotion of products that imitate its drugs, Mounjaro and Zepbound.
彭博报告补充说，这家美国制药巨头已向远程医疗公司、配制药房和医疗美容中心发出数百封停止与终止信函，要求他们停止生产、销售和推广仿制其药物 Mounjaro 和 Zepbound 的产品。
The industry estimates that compounded versions of drugs from Lilly and Novo Nordisk A/S (NYSE:NVO) may be generating up to $1 billion in annual sales, with hundreds of thousands of Americans using them. However, compounded drugs have certain risks, as they aren't subject to regulatory review for safety and efficacy like brand-name or generic medications.
行业估计，礼来和诺和诺德（NYSE:NVO）的复方药物可能每年创造高达10亿美元的销售额，数十万美国人在使用。然而，复方药物存在一定风险，因为它们不像品牌名或通用药品那样需要接受安全性和有效性的监管审查。
Despite these concerns, compounded drugs provide an alternative for patients facing shortages of weight-loss medications and are often a more affordable option, costing significantly less than the over $1,000 monthly price tag of brand-name injections.
尽管存在这些担忧，复方药物为面临减肥药短缺的患者提供了一种替代选择，通常是一个更经济的选择，其成本明显低于品牌注射药品每月逾1000美元的标价。
The trade group has urged pharmacies to "immediately stop preparing and dispensing compounded versions of Mounjaro and Zepbound." While some have complied, others insist they will keep producing customized versions of Lilly's drugs for specific patients.
行业团体敦促药店"立即停止准备和发放Mounjaro和Zepbound的复方药物"。虽然一些人已经遵从，但其他人坚持他们将继续为特定患者生产定制版的礼来药物。
U.S. regulations permit compounders to create tailored versions of medications when prescribed for medical necessity.
美国法规允许化学调配人员在处方用于医疗必要性时创造定制版本的药物。
Price Action: LLY stock is down 0.77% at $912.67 at last check Thursday.
股价表现：LLY股票在周四最后检查时下跌0.77%，报912.67美元。
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Image by Mohammed_Al_Ali via Shutterstock
图片来自Shutterstock的Mohammed_Al_Ali。
