January 12th 2026
January 6th 2026
FDA approves new denosumab biosimilars, enhancing treatment options for osteoporosis and bone metastases while driving competition and cost savings.
December 19th 2025
Discover the top 5 regulatory biosimilar news of 2025, highlighting FDA approvals that enhance treatment options and competition in health care.
December 16th 2025
Biosimilar developers achieve key European approvals for denosumab and golimumab, enhancing patient access while facing US market entry delays.
December 11th 2025
FDA's new guidance clarifies promotional practices for biosimilars, ensuring accurate marketing and preventing misleading claims in the competitive landscape.
Senate Bill Seeks to Improve Access to Affordable Rx Drugs
Humira Not Cost Effective for RA, ICER Report Concludes
Multiple Challenges Predicted for Biosimilars in 2017
European Drug Agency's Move Out of London, Spurred By Brexit, Could Disrupt Pipeline
Nominee for FDA Commissioner Vows to Strike Balance Before Senate Panel
Rituxan Given Breakthrough Therapy Designation for Pemphigus Vulgaris
New Drug Approved for MS, First With PPMS Indication
Dupilumab, a Biologic Treatment for Eczema, Approved by FDA
Policy Briefing Calls for More Efficient Biosimilar Approval Process
Amgen Gains EC Approval for Biosimilar to Adalimumab
Amgen Files for EU Approval of Its Herceptin Biosimilar for Breast Cancer
Congressional Hearing on FDA User Fees Tackles Issues Affecting Biosimilar Approvals
Trump Administration Budget Blueprint Comes With Major Cuts to Health and Science
Dupilumab Improves Signs and Symptoms of Atopic Dermatitis Without Safety Issues
Greater Transparency at FDA Would Bring More Biosimilars to Market, Experts Say
Dr Scott Gottlieb, Trump's FDA Pick, a Consistent Supporter of Biosimilar Innovation
Mylan's Settlement With Genentech and Roche Opens US Market for Trastuzumab Biosimilar
European Industry Groups Urge Caution on Biosimilar Switching
Amgen Lawsuit Against Coherus Alleges Misappropriation of Neulasta Trade Secrets
Siliq Approved Without a Suffix
Sandoz Releases Efficacy Data for Its Humira Biosimilar
FDA's Director of Drug Evaluation Urges Congress to Pass the BsUFA Reauthorization
US and EU Agree on Mutual Recognition of Drug Manufacturing Inspections
Bioequivalence Endpoints Successfully Met for Humira Biosimilar, Coherus Announces
Diabetes Drugs Could Be Next Frontier of Biosimilar Development
Will the Biosimilars Bubble Burst Even Before It Expands?
New Mexico Senate Passes Bill for Biosimilar Substitution
FDA Should Forge Ahead on Biosimilar Drug Reviews: A Rheumatologist's Opinion
Truxima Receives Approval in EU for Autoimmune, Oncology Indications
Will US Follow UK on Managed Biosimilar Switching of IBD Patients on Infliximab?
