The FDA is “deeply concerned” after the presence of a third nitrosamine impurity is found in certain generic ARB medicines; Hetero Labs recalls 87 lots of losartan tablets after recent FDA tests show NMBA levels higher than the agency’s interim acceptable intake limits.
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said that the agency is “deeply concerned” about the presence of a third nitrosamine impurity that has been found in certain generic angiotensin II receptor blocker (ARB) medicines.
India’s Hetero Labs has announced a recall of 87 lots of losartan potassium tablets in three strengths – 25mg, 50mg...
Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.
The UPC Court of Appeal has signaled that in pharma disputes, being ready to launch can be as risky as actually launching. In a major setback for Zentiva, the court ruled that completing certain steps well before patent expiry amounted to “setting the stage” for infringement.
Hikma is seeing increased US demand for its generic Victoza (liraglutide) after the end of semaglutide compounding lifted prices for Novo Nordisk’s Ozempic and Wegovy. Meanwhile, the company is not for now pursuing semaglutide generics in the US or EU due to patent protection, but is targeting MENA.
Alongside biosimilars, Lupin sees injectable products as one of the key growth drivers in the US, as competition for two of its “material” drugs and proposed tariffs are looming over the firm.
Harrow is taking aim at launching new partner Samsung Bioepis’ Byooviz biosimilar to Lucentis in 2026.
The UPC Court of Appeal has signaled that in pharma disputes, being ready to launch can be as risky as actually launching. In a major setback for Zentiva, the court ruled that completing certain steps well before patent expiry amounted to “setting the stage” for infringement.
Gedeon Richter’s management discussed timelines for two key biosimilars during the firm’s first-half earnings call, while also revealing how the firm’s General Medicines division had suffered setbacks in the three months to June 30.
