Latest from Dean Rudge
The US Federal Circuit’s March 2025 decision affirming a lower court’s determination on both induced infringement and non-obviousness concerning a key patent shielding Janssen’s Invega Trinza (paliperidone palmitate) long-acting injectable is set to stand – for now.
The FDA has concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements, and that there was no “mistake” or untrue statement in the original ANDA approvals, as it denied Vanda’s citizen petition.
Fresenius Kabi has become the second company to launch US denosumab biosimilars, taking its current biosimilars portfolio up to six products.
A proposed biosimilar to one of the lesser spoken about monoclonal antibodies for inflammatory conditions, UCB Pharma’s Cimzia, is the latest candidate to join the significant commercial partnership between Alvotech and Advanz Pharma.
Generics Bulletin previews the most noteworthy and anticipated events for July 2025.
The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).