The pharmaceutical landscape enters 2025 with a mix of challenges and opportunities, with the potential to shape the future of drug access and affordability for patients across the nation.
Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.
Eculizumab biosimilar Elizaria demonstrates long-term safety and efficacy comparable with the reference product Soliris in patients with paroxysmal nocturnal hemoglobinuria (PNH), according to a Russian study that expanded on a previous phase 3 study.
Biosimilar teriparatide has been shown to be as safe and effective as its reference product for osteoporosis treatment, potentially enabling significant cost savings in Japan’s health care system while addressing persistent misconceptions about biosimilar quality.