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.
禮來（紐交所: LLY）正在加大對允許臨時生產和銷售其暢銷藥物減肥仿製藥的配製公司的法律攻勢。
Last week, the FDA determined the shortage of Eli Lilly tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved.
上週，FDA確定了禮來替利塞肽注射劑的短缺問題已得到解決。替利塞肽是一種胰高血糖素樣肽-1（GLP-1）藥物。
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.
美國衛生監管機構提醒複方製劑師不要製作FDA批准藥物的複製品而受到法律限制。這一更新引起了醫療專業人員、患者和藥物混合製劑廠的關注。
Also Read: Regeneron Chief Flags Health Risks with Popular Weight-Loss Medications Like Ozempic, Says Company Targets Muscle Preservation For Its Obesity Drugs.
此外閱讀: Regeneron首席指出奧澤帕等受歡迎減肥藥物存在健康風險，並表示公司以肌肉保留作爲肥胖藥物的目標。
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，曾因生產不足而短缺的蒂澤帕肽注射劑，商標爲Mounjaro和Zepbound，現已得以生產，使混合製劑藥房和外包設施能夠生產該藥以滿足患者需求。
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.
配製集團外包設施協會和遠衛睿自定義配製提出投訴，聲稱將該藥從短缺清單中移除僅基於製造商的生產能力。
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未經事先通知或公開磋商即決定撤回該藥物的做法遭到批評，認爲這將剝奪患者的基本護理，可能會推高藥物價格，並偏袒特殊利益。
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.
彭博報告補充說，這家美國製藥巨頭已向遠程醫療公司、配製藥房和醫療美容中心發出數百封停止與終止信函，要求他們停止生產、銷售和推廣仿製其藥物 Mounjaro 和 Zepbound 的產品。
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.
行業估計，禮來和諾和諾德（NYSE:NVO）的複方藥物可能每年創造高達10億美元的銷售額，數十萬美國人在使用。然而，複方藥物存在一定風險，因爲它們不像品牌名或通用藥品那樣需要接受安全性和有效性的監管審查。
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.
儘管存在這些擔憂，複方藥物爲面臨減肥藥短缺的患者提供了一種替代選擇，通常是一個更經濟的選擇，其成本明顯低於品牌注射藥品每月逾1000美元的標價。
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.
行業團體敦促藥店"立即停止準備和發放Mounjaro和Zepbound的複方藥物"。雖然一些人已經遵從，但其他人堅持他們將繼續爲特定患者生產定製版的禮來藥物。
U.S. regulations permit compounders to create tailored versions of medications when prescribed for medical necessity.
美國法規允許化學調配人員在處方用於醫療必要性時創造定製版本的藥物。
Price Action: LLY stock is down 0.77% at $912.67 at last check Thursday.
股價表現：LLY股票在週四最後檢查時下跌0.77%，報912.67美元。
- TD Bank To Face $3B Penalty, Growth Limits In US Settlement Over Anti-Money Laundering Failures
- 加拿大豆腐腦( The Toronto-Dominion Bank )將面臨30億美元罰款，在美國協議中限制增長，原因是反洗錢失敗。
Image by Mohammed_Al_Ali via Shutterstock
圖片來自Shutterstock的Mohammed_Al_Ali。
