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 ...

FDA approves multiple denosumab biosimilars, enhancing market access and introducing interchangeability, boosting competition in bone health therapies.

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 The FDA has issued draft guidance that ...

A recent study confirms the stability of XSB-001 biosimilar for retinal diseases under realistic clinical handling conditions. Ranibizumab, an anti–vascular endothelial growth factor (VEGF)–A fragment ...

Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

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

Global Head Clinical Development, Biocon BiologicsElena Wolff-Holz, MD, global head of clinical development at Biocon Biologics, discussed the approval of BMAb-1200, a biosimilar to reference ...

James D. Chambers, PhD, MPharm, MSc, is an associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies. Chambers leads the Tufts Medical Center Specialty ...