Novo Nordisk and Eli Lilly are asking the FDA to block compounders from making copies of their blockbuster weight-loss drugs, arguing that such versions could be unsafe. Why it matters: This could slow a medical revolution that promises to reshape America's economy — and Americans themselves. - It also may mean tighter margins for telehealth companies like Ro and Hims & Hers, although both also sell branded versions of GLP-1 drugs.
Driving the news: Novo last week nominated semaglutide — the active ingredient in Ozempic and Wegovy — to join a list of drugs that the FDA considers too complex to be made by compounders. - This came after a similar (albeit more redacted) filing from Eli Lilly over tirzepatide, the active ingredient in its Mounjaro and Zepbound.
The big picture: This is just part of a multi-pronged legal approach by the pharma giants, which claim to be protecting patients. Compounders, on the other hand, argue that the moves are to protect profits. - Many compounders produce the drugs for around $100 a month, whereas the list price for Novo's Wegovy is more than $1,300.
Zoom in: Beyond safety, there also is a question of shortages. - Semaglutide injections remain on the FDA's shortages list, which initially enabled compounding.
- Tirzepatide injections were removed from the list earlier this month, before the FDA decided to reevaluate that decision after being sued by the compounders.
Look ahead: If the FDA entertains the safety filings, the subsequent process could take upward of a year. The bottom line: We've previously discussed the parallels between GLP-1 drugs and LLM-fueled artificial intelligence. - Let's add another: Incumbent calls for more safety guardrails.
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