U.S. health authorities will prohibit the sale of the obesity treatment "Zepbound" (active ingredient tirzepatide), which was temporarily authorized in 2022, starting in February next year. This decision follows the resolution of supply shortages for Zepbound in October, leading to increasing backlash as local generic drug manufacturers are expected to be significantly impacted.
The U.S. Food and Drug Administration (FDA) stated on the 19th (local time) that "the shortage of Zepbound has been fully resolved" and added, "Effective February 18 of next year, the production and sale of generics, including combination products from small pharmaceutical companies and pharmacies, will be halted.
The FDA manages drugs that are in high demand but cannot keep up with supply by placing them on a "shortage list." Drugs on this list can be manufactured and sold by compounding pharmacies or small pharmaceutical companies with the same active ingredients, provided they have received FDA approval.
Tirzepatide from the U.S. company Eli Lilly is a drug that mimics the hormone glucagon-like peptide (GLP)-1, which induces a feeling of fullness. It slows down the digestion of food in the stomach, creating a feeling of satiety and suppressing appetite, resulting in weight loss. Initially approved as a diabetes treatment named Mounjaro, its weight loss effects were confirmed, leading to its release as the obesity treatment Zepbound in November last year.
After the release of Mounjaro, demand outpaced supply, and it was included in the shortage list in December 2022. Subsequently, Zepbound was also added to the list in April this year. The active ingredient tirzepatide has been designated as a shortage drug for approximately two years, allowing for the continued sale of generics. Since the temporary allowance for generics impacted the sales of the original drug, Eli Lilly invested about 12 trillion won to expand production facilities, including in the U.S. and Ireland, to exit the shortage list.
Zepbound is not covered by public insurance in the U.S., resulting in a significant price burden. The local price is approximately $650 (about 860,000 won) for a month's prescription. The price of the generic is at least $199 (about 289,000 won) per month, which is one-fifth of the original drug's price. Consequently, there has been a significant increase in consumers seeking generics. As of July, more than 2 million Americans are using generics of Wigovy and Zepbound.
However, generics have continuously raised concerns about safety. In fact, issues have surfaced regarding illegal manufacturers selling generics online without FDA approval. The original obesity drug manufacturers have asked the FDA to prohibit the manufacturing of generics, citing patient safety concerns.
Eli Lilly issued a statement to the FDA in August, noting, "Impurities were found in our generics, which could trigger immune reactions in patients, raising safety concerns." Novo Nordisk of Denmark, the manufacturer of Wigovy, which competes with Zepbound, also issued a similar statement to the FDA in October.
With the FDA's prohibition on the sale of generics, specialized generic companies and pharmacies have begun to feel the impact. Share prices of Hims & Hers Health, which has developed and sold combination products, dropped over 9% immediately after the announcement of Zepbound's removal from the list in October, and fell about 8% following the FDA's statement.
The generic drug industry has reacted strongly. Scott Brunner, president of the Alliance for Pharmacy Compounding, asserted, "Regulators do not have the data necessary to determine whether the shortage is truly over" and warned, "If they cannot meet the demand of over 2 million existing consumers, the consequences will fall entirely on the consumers. " In response, the FDA stated, "We are continuously monitoring the production situation of Eli Lilly's Zepbound, and if demand exceeds the available supply, it may again be included on the shortage list."
The generic obesity drugs, which have raised safety concerns in the U.S., may also pose problems domestically. There are no effective methods to prevent importing U.S. generics. While buying prescription drugs from abroad is illegal, it is realistically impossible to monitor individuals bringing back medications from overseas trips. The Ministry of Food and Drug Safety is requesting the Korea Communications Standards Commission to block sites when online sales or advertisements of pharmaceuticals are confirmed based on self-monitoring and reports.
An official from the Ministry of Food and Drug Safety stated, "Specialist drugs such as obesity treatments must be administered in accordance with prescribed dosages and instructions from physicians and pharmacists during visits to hospitals and pharmacies," and urged, "Caution is also necessary regarding generics of obesity drugs that are temporarily allowed in the U.S. right now."