Discover the top 5 regulatory biosimilar news of 2025, highlighting FDA approvals that enhance treatment options and ...

Tyruko, the first natalizumab biosimilar for multiple sclerosis, promises significant savings and competition in the US market.

Biosimilar developers achieve key European approvals for denosumab and golimumab, enhancing patient access while facing US market entry delays.

FDA's new guidance clarifies promotional practices for biosimilars, ensuring accurate marketing and preventing misleading ...

The Center for Biosimilars connects professionals with insights on biosimilars, health economics, regulatory outcomes, and ...

October 2025 marks a transformative period for biosimilars, with new FDA guidelines accelerating approvals and promising significant cost savings for health care. October 2025 proved to be a pivotal ...

FDA's new guidance streamlines biosimilar development, reducing costs and regulatory hurdles and potentially enhancing market access and affordability. The FDA has issued draft guidance that ...

Biosimilars significantly reduce health care costs in Australia, enhancing access to biologics while driving price competition in the pharmaceutical market. The economic impact of biosimilars on the ...

Pediatric infliximab biosimilar use has risen significantly, reflecting evolving treatment patterns in inflammatory bowel disease (IBD) among children and young adults. Infliximab biosimilar ...

While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more ...

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 ...

January 1 marks the launch of the first biosimilar referencing Stelara (ustekinumab) in the US, ushering in a new class of lower-cost medicines for patients with rheumatic and gastrointestinal ...