Novo Nordisk A/S
This scarcity in Europe, attributed to the drug's weight-reducing effects, persists, as outlined in a statement posted on the website of the German healthcare regulator BfArM by Novo on Tuesday.
The company advised physicians to limit prescriptions to patients already undergoing Ozempic therapy, emphasizing the drug's intended use in diabetes treatment.
Additionally, Novo Nordisk reiterated the importance of prescribing Ozempic strictly for approved diabetic indications.
The company pointed out ample supplies of Wegovy, an obesity medication containing the same active ingredient as Ozempic.
Despite previous assurances from Novo that the supply situation for new Ozempic patients in Europe would improve in the first quarter of the year, challenges persist, with intermittent shortages anticipated throughout 2024.
To address the issue of off-label prescriptions of Ozempic for weight loss, Novo announced measures in November last year to ration Ozempic starter kits in Europe and reduce the supply of another diabetes drug, Victoza, to prioritize Ozempic production.
However, Novo cautioned that the 0.25 mg starter strength of Ozempic will remain unavailable in Germany during the second quarter, with limited volumes of the 0.5 mg intermediate dose accessible.
Meanwhile, in a separate development, a Chinese pharmaceutical company, Hangzhou Jiuyuan Gene Engineering, has unveiled a biosimilar version of Novo Nordisk's Ozempic.
Named Jiyoutai, the drug is awaiting approval for sale in China to manage blood sugar levels in type 2 diabetes patients.
Reuters highlighted that patents in China on Ozempic and related drug Wegovy are set to expire in 2026.
Novo's Ozempic sales in China more than doubled last year to DKK 4.8 billion ($694 million), accounting for 5% of global Ozempic sales.
"Unless the competent court finally decides this patent is invalid, we will not be able to commercialize JY29-2 (Jiyoutai) before the expiration of this patent," Reuters noted, citing Jiuyuan Gene.
Tuesday, the FDA's website indicated that Eli Lilly And Co's
The doses of 7.5, 10, 12.5, and 15 milligrams are limited until April, while lower doses are available.
Price Action: NVO shares are up 0.80% at $127.48 on the last check Wednesday.