Also known as: Xolair
Xolair may be dropped from Medicare price negotiations as a biosimilar launch looms. The CMS must decide if the biosimilar is a true competitor. The outcome could set precedent for future biosimilar-facing selections.
The Senate HELP Committee advanced a bill to streamline biosimilar approvals by relying on analytical tests, potentially cutting development costs and time. The FDA has issued guidance removing comparative efficacy studies and is working to speed post-exclusivity approvals. Combined with administration support and PBM reforms, these moves aim to increase biosimilar competition and reduce drug prices.
Recent research identifies hidden systemic inflammation in primary ciliary dyskinesia via oral swab and confirms asthma biologics do not increase respiratory infection risk in pediatric patients.
Two studies examined blood biomarkers for omalizumab response in chronic spontaneous urticaria. Basophil histamine content did not predict response, while higher baseline monocyte counts were linked to complete remission in a 52-patient retrospective analysis.
Novartis received EU approval for Rhapsido (remibrutinib) as the first oral targeted treatment for chronic spontaneous urticaria. Phase 3 data also showed significant efficacy in chronic inducible urticaria, with filings underway for additional indications.
Pfizer's tilrekimig met its primary endpoint in a mid-stage eczema trial and will advance to late-stage testing. Separately, oral remibrutinib demonstrated rapid efficacy in treating peanut allergy in a phase II study.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06934200 |
Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels |
RECRUITING | PHASE2 |
| NCT06438757 |
Trial of JYB1904 in Patients With Allergic Asthma |
COMPLETED | PHASE2 |
| NCT06042478 |
Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension. |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT00382148 |
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g |
COMPLETED | PHASE2 |
