FDA Approved: EPYSQLI — Original Application (Teva Pharmaceuticals USA, Inc.)

View source ↗

Summary

FDA approved EPYSQLI (eculizumab-aagh) from Teva as a biosimilar to Soliris, for the same indications as the reference product.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

• Atypical Hemolytic Uremic Syndrome
• Generalized Myasthenia Gravis
• Paroxysmal Nocturnal Hemoglobinuria

Drugs mentioned

• EPYSQLI (eculizumab-aagh)

Snippet

ORIG AP for EPYSQLI (ECULIZUMAB-AAGH)