Generics manufacturers looking to target the popular weight-loss drug Saxenda – a precursor therapy to Novo Nordisk’s wildly successful Wegovy – can look to the US FDA’s latest product specific guidance on developing their own versions of the GLP-1 receptor agonist.
Novo Nordisk’s self-injectable GLP-1 receptor agonist Saxenda (liraglutide), the heavily advertised and extensively used treatment for obesity, is among 32 new and revised product specific guidance documents published by the US Food and Drug Administration, which includes 25 PSGs for products with no approved abbreviated new drug application products.
Approved by the FDA for chronic weight management in adults in December 2014, Saxenda was at the end of 2020 handed a further approval for the
Adalvo and Gedeon Richter have announced a global co-development deal for semaglutide for obesity. Adalvo CEO Anil Okay spoke to Generics Bulletin about the alliance as well as the broader competitive landscape for GLP-1s.
After receiving a favorable court ruling last year, Lupin has secured its first-place spot for generic tolvaptan tablets in the US.
The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.
Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.
