For how we live.
In a 462-person phase 3 trial, a synthesised copy of semaglutide, HD1916, cut body weight 13.1% over 44 weeks against 14.4% for the branded drug — inside the margin set for calling them equivalent.
A hybrid public meeting on 26 October will discuss proposed BsUFA IV recommendations. The fees that fund FDA review of biosimilar applications expire in September 2027 and need new legislation to continue.
The FDA's approval bar requires no clinically meaningful difference from the original, and a large switching trial found no loss of control. The savings gap is a market problem, not a safety one.
In the head-to-head OVERLORD-MS trial, 92.2% on rituximab and 94.8% on ocrelizumab had no new MRI lesions from months 6 to 24, meeting the prespecified bar for noninferiority.
Seven of those nine were denosumab. The committee's September opinions also covered an RSV antibody for infants, a first EU treatment for IgG4-related disease, and four withdrawn applications.