January 21st 2025
By Skylar Jeremias
In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.
January 18th 2025
By Deana Ferreri, PhD
Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the biosimliar's FDA approval.
January 16th 2025
Biosimilar launches achieve a 53% market share and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to Samsung Bioepis’ most recent market report, showcasing notable pricing trends and market share disparities across therapeutic areas.
January 14th 2025
The nationwide mandatory switch from Humira (reference adalimumab) to biosimilar adalimumab in Denmark led to no increase in total health care costs over 9 months, with significant cost reductions for those who switched to GP2017 specifically, highlighting the economic feasibility of biosimilar adoption.
January 5th 2025
Tiago Biachi, MD, PhD, emphasizes that biosimilars are vital for reducing financial toxicity and ensuring equitable, affordable access to advanced treatments in gastrointestinal (GI) cancer care, while calling for dynamic policies and greater cost awareness among clinicians.
January 2nd 2025
To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.
January 1st 2025
By Courtney Flaherty
First-line cetuximab beta injection has received NMPA marketing approval in RAS/BRAF wild-type metastatic colorectal cancer.
December 21st 2024
The top gastroenterology biosimilar news from 2024 highlight fluctuations in the adalimumab biosimilar market throughout the year, while FDA and European approvals for ustekinumab biosimilars are set to improve access and reduce costs for patients with Crohn disease and ulcerative colitis.
December 18th 2024
The FDA approved Celltrion's Steqeyma (ustekinumab-stba), making it the seventh biosimilar slated to compete against blockbuster Stelara (reference ustekinumab) in 2025.
December 14th 2024
A real-world study in France found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation.
