March 31st 2025
By Skylar Jeremias
Alvotech's 427% revenue surge in 2024—fueled by its biosimilar portfolio and global expansion—highlights the booming profitability of biosimilars despite financial hurdles.
March 24th 2025
By Sarfaraz K. Niazi, PhD
Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and technological feasibility, whereas other biologics encounter development challenges but may see increased adoption as regulatory frameworks advance.
March 17th 2025
Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
March 10th 2025
Sarfaraz Niazi, PhD, urges the FDA to let the USPharmacopeia (USP) create product release specifications for biosimilars to cut costs, speed development, and enhance accessibility.
March 6th 2025
Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
February 17th 2025
Sarfaraz K. Niazi, PhD, gives his opinion on how the recent IQVIA report “Assessing the Biosimilar Void in the US” could be improved for the future.
February 11th 2025
By Cameron Santoro
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.
February 5th 2025
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.
February 3rd 2025
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.
January 28th 2025
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.
