In the USA, the Food and Drug Administration has announced the availability of a draft guidance for industry which could smooth the path for biosimilars developers to gain interchangeable status for their products. 21 June 2024
The US Food and Drug Administration has approved US biotech major Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. 30 May 2024
Chief Executive Officers of the world’s largest generic and biosimilar medicines companies recently met in Vienna, Austria, to provide strategic advice to the International Generic and Biosimilar Medicines Association (IGBA). 29 May 2024
A commercial stage biopharmaceutical R&D company, focused on the development of products that address the medical challenges in the therapeutic area of anti-infectives.
The proposed US BIOSECURE Act was this week left out of the House Rules Committee’s final list of amendments to be voted on for inclusion in the NDAA, an agreement that specifies the budget and spending for the US Department of Defense. 15 June 2024
The date for the generics and biosimilars specialist Sandoz to spin out from its parent company Novartis (NOVN: VX) has been announced. 25 September 2023
As had long been expected, Novartis has announced plans to hive off its generics business, Sandoz, creating a new publicly-traded company. 25 August 2022