Biosimilars News
🇺🇸 FDAFDA breaking news and regulatory updates for BD, investors, and analysts
Showing 1–12 of 14 articles
FDA Draft Guidance Slashes Biosimilar PK Study Costs, Accelerating Market Entry
FDA Approves LANGLARA Interchangeable Biosimilar to Lantus Insulin - Lannett Company Enters Diabetes Market
Teva Reports Strong Q1 2026 Results as PONLIMSI Biosimilar Receives FDA Approval and Olanzapine LAI Advances
Teva's PONLIMSI Biosimilar Receives FDA Approval for All Prolia Indications as Q1 2026 Results Show Strong Growth
Sun Pharma Acquires Organon for $11.75 Billion in Major Pharmaceutical Merger
Generic Drug Forum 2026: Key Takeaways on Market & Regulation
Outlook Therapeutics Completes FDA Dispute Resolution Meeting for LYTENAVA Bevacizumab Biosimilar
FDA Biosimilar Substitution Policy Update: Key Regulatory Changes
FDA Approves Riabni Biosimilar: Expanding NHL Treatment Options
FDA Approves BioClone's Clone-Remicade: Cheaper Alternative to Remicade
FDA Approves Biosimilar Insulin Lispro: What You Need to Know
FDA Priority Review Granted to CardioGen's RevivCor for Heart Failure