Inebilizumab

• The FDA has approved Amgen's UPLIZNA (inebilizumab-cdon) as the first and only targeted treatment specifically for IgG4-related disease, following positive results from the Phase III MITIGATE trial. • The MITIGATE trial demonstrated an 87% reduction in disease flare risk compared to placebo, with the study enrolling 135 adults across 80 sites in 22 countries. • Multiple companies including Sanofi and Zenas BioPharma are advancing a robust pipeline of approximately 10 therapies for IgG4-related disease, potentially transforming treatment options for this rare inflammatory condition.

• Amgen's biosimilar of Johnson & Johnson's Stelara achieved $150 million in first-quarter sales, contributing to the company's $735 million total biosimilar revenue, which grew 35% year-over-year. • The biotech company's strategic investment in biosimilars now accounts for approximately 9% of total revenue, offsetting pressure on branded products while outperforming some of its innovative medicines. • Amgen continues expanding its biosimilar portfolio with recent launches of Eylea copycat and upcoming Soliris biosimilar, while also developing competitors to blockbuster checkpoint inhibitors Opdivo and Keytruda.

• Pacira BioSciences has reached a settlement agreement with Fresenius, Jiangsu Hengrui Pharmaceuticals, and eVenus Pharmaceuticals regarding patents for its pain management drug Exparel, protecting market exclusivity until 2030. • Under the agreement, Fresenius will begin limited-volume sales of generic bupivacaine liposome injectable suspension in early 2030, with gradual market share increases reaching the high thirties percent by the final years of the agreement. • The settlement strategically preserves Pacira's market dominance for its lead drug Exparel for nearly a decade before allowing controlled generic entry, significantly extending protection beyond potential patent challenges.

The FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with IgG4-related disease, a chronic immune-mediated inflammatory condition that can cause permanent organ damage.

• Several major pharmaceutical companies await critical FDA decisions in April, with Sanofi's Dupixent, Amgen's Uplizna, and Bristol's Opdivo all seeking approval for new indications. • Johnson & Johnson aims to establish a new therapeutic franchise with nipocalimab, potentially marking a significant expansion in their immunology portfolio. • Stealth Biotherapeutics faces a crucial regulatory milestone that industry analysts describe as a "day of reckoning" for the company's development strategy and market position.