Biosimilars
🇺🇸 FDA Page 2FDA news and analysis for pharmaceutical BD, investment, and market access · 12 articles on this page
Track global biosimilar approvals, market entry strategies, and regulatory pathways. Gain critical intelligence for your pharmaceutical BD and investment decisions.
Showing 13–24 of 27 articles
Generic Drug Forum 2026: Key Takeaways on Market & Regulation
general · 8 min
Dr. Sarah MitchellSAHPRA Biosimilars Approval: Pathway Analysis & Impact on Affordable Medicines
SAHPRA · biosimilars · 11 min
Dr. Natalie HughesOutlook Therapeutics Completes FDA Dispute Resolution Meeting for LYTENAVA Bevacizumab Biosimilar
FDA · 2 min
Dr. Sarah MitchellPANDRH Regulatory Harmonization: What You Need to Know About Biosimilar Market Entry in LATAM
PANDRH · biosimilars · 9 min
Dr. Elena RossiUS Oncology Biosimilar Landscape 2026: Pricing & Market Access Insights
FDA · oncology · 9 min
Dr. Sarah MitchellRise of Biosimilars: Market Impact Post-2026 Patent Expirations in US
FDA · Biologics · 11 min
Dr. Sarah MitchellCOFEPRIS Biocomparables Pathway: What You Need to Know
COFEPRIS · biosimilars · 4 min
Dr. Yuki TanakaFDA Biosimilar Substitution Policy Update: Key Regulatory Changes
FDA · biosimilars · 6 min
Dr. Sarah MitchellFDA Approves Riabni Biosimilar: Expanding NHL Treatment Options
FDA · Oncology · 4 min
Dr. Sarah MitchellBiosimilar Competition Impact: US Biologics Market Analysis 2026
FDA · Oncology · 13 min
Dr. Sarah MitchellFDA Approves BioClone's Clone-Remicade: Cheaper Alternative to Remicade
FDA · autoimmune diseases · 4 min
Dr. Sarah MitchellFDA Approves Biosimilar Insulin Lispro: What You Need to Know
FDA · Diabetes Mellitus · 4 min
Dr. Sarah MitchellExplore intelligence