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Biosimilars

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FDA 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 28 articles

High impact NewsApr 27, 2026

Sun Pharma Acquires Organon for $11.75 Billion in Major Pharmaceutical Merger

Multiple therapeutic areas (women's health, biosimilars, established brands) · 3 min

Michael Rodriguez
High impact NewsApr 24, 2026

Generic Drug Forum 2026: Key Takeaways on Market & Regulation

general · 8 min

Michael Rodriguez
Medium impact AnalysisApr 23, 2026

SAHPRA Biosimilars Approval: Pathway Analysis & Impact on Affordable Medicines

SAHPRA · biosimilars · 11 min

Sarah Chen
High impact NewsApr 22, 2026

Outlook Therapeutics Completes FDA Dispute Resolution Meeting for LYTENAVA Bevacizumab Biosimilar

FDA · 2 min

Sarah Chen
Standard impact AnalysisApr 22, 2026

PANDRH Regulatory Harmonization: What You Need to Know About Biosimilar Market Entry in LATAM

PANDRH · biosimilars · 9 min

Michael Rodriguez
Standard impact AnalysisApr 21, 2026

US Oncology Biosimilar Landscape 2026: Pricing & Market Access Insights

FDA · oncology · 9 min

Sarah Chen
Standard impact AnalysisApr 21, 2026

Rise of Biosimilars: Market Impact Post-2026 Patent Expirations in US

FDA · Biologics · 11 min

Sarah Chen
High impact AnalysisApr 21, 2026

COFEPRIS Biocomparables Pathway: What You Need to Know

COFEPRIS · biosimilars · 4 min

Michael Rodriguez
Medium impact NewsApr 20, 2026

FDA Biosimilar Substitution Policy Update: Key Regulatory Changes

FDA · biosimilars · 6 min

Michael Rodriguez
High impact NewsApr 20, 2026

FDA Approves Riabni Biosimilar: Expanding NHL Treatment Options

FDA · Oncology · 4 min

Michael Rodriguez
Medium impact AnalysisApr 20, 2026

Biosimilar Competition Impact: US Biologics Market Analysis 2026

FDA · Oncology · 13 min

Sarah Chen
High impact NewsApr 20, 2026

FDA Approves BioClone's Clone-Remicade: Cheaper Alternative to Remicade

FDA · autoimmune diseases · 4 min

Michael Rodriguez