June 12, 2026
Clinical Updates
Hympavzi® (marstacimab-hncq) – Expanded indications and new strength
June 9, 2026 - Pfizer announced the FDA approval of Hympavzi (marstacimab-hncq), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors.
Drug Approvals
Ranluspec™ (ranibizumab-hkdz) – New biosimilar approval
June 2, 2026 - Lupin announced the FDA approval of Ranluspec (ranibizumab-hkdz), biosimilar and interchangeable to Genentech’s Lucentis® (ranibizumab).
New Generics
Opsumit® (macitentan) – First-time generic
June 8, 2026 - Teva launched an AB-rated generic version of Janssen’s Opsumit (macitentan) tablets.
New Generics
Xeljanz® (tofacitinib) – First-time generic
June 3, 2026 - Hikma launched an AA-rated generic version of Pfizer’s Xeljanz (tofacitinib) oral solution. On June 4, 2026, Breckenridge launched an AB-rated generic version of Pfizer’s Xeljanz tablets.
New Generics
Xeljanz® XR (tofacitinib) – First-time generic
June 3, 2026 - Aurobindo and Zydus launched AB-rated generic versions of Xeljanz XR (tofacitinib) 11 mg tablets. In addition, Zydus also launched an AB-rated generic version of Xeljanz XR 22 mg tablets.