2 Department of Pharmaceutical Sciences, State University of New York, Buffalo, NY, 14214, USA
At the highest dose of 12 mg, participants achieved mean body weight reduction of 16.9% compared to 3.0% with placebo
Challengers received the Abbreviated New Drug Application (ANDA) pathway, which allows a generic to demonstrate bioequivalence to the reference listed drug without repeating the innovators clinical trials, plus a research safe harbor allowing them to conduct development activities during the patent term without infringement liability, and the 180-day exclusivity reward for challenging brand patents via P.IV certification
Last, development of new anti-TNF- forms and sophisticated TNFR targeting might optimize drug bioavailability, enhance their local efficacy and minimize adverse effects, while combination with other agents might refine disease outcomes using lower drug doses