Formulary Watch |

FDA Approves First Interchangeable Stelara Biosimilar

Amgen’s Wezlana is approved to treat multiple inflammatory diseases. It is expected to launch no later than Jan. 1, 2025

FDA Assigns Goal Date for Mavorixafor for Rare Immunodeficiency Disease

If approved, mavorixafor would be the first therapy for WHIM syndrome, an ultra-rare disease that can cause recurrent lung infections, papillomavirus-related warts, and an increased risk of developing certain types of cancer. The PDUFA date is April 30, 2024.

Payer Coverage of Biosimilars Varies by Preference

CarePartners Adds Yuflyma to its Cost Savings Program

FDA Approves First Treatment for Nasopharyngeal Carcinoma

Loqtorzi is indicated in combination with chemotherapy for first-line treatment and as monotherapy for patients with disease progression on or after platinum containing chemotherapy.

FDA Approves New Duchenne Muscular Dystrophy Drug

Agamree is a novel corticosteroid that will be available in the first quarter of 2024.

J&J Warns of Risk of Respiratory Depression with Spravato

Lilly’s First-in-Class Therapy for Ulcerative Colitis Get FDA Approval

Mirikizumab — now with the brand name — Omvoh has a list price of $9,593 per month for the IV formulation and $10,360 per subcutaneous administration.

Study Reveals Inconsistent Wait Times for Decisions on Cancer Drug Coverage

Recall Impacts Exela and Civica Brands

In total, 11 lots of three different products have been recalled because of silicone found in retained samples.

FDA Sets New Review Date for Bladder Cancer Immunotherapy

N-803 — with the brand name Anktiva — plus the Bacillus Calmette-Guérin vaccine is being reviewed by the FDA to treat non-muscle-invasive bladder cancer. The goal date is April 23, 2023.

Subcutaneous Leqembi Clears More Amyloid than IV Formulation

FDA Assigns Review Date for Resubmission of Kidney Disease Treatment

Akebia has resubmitted its NDA for vadadustat with postmarketing safety data from Japan, where it has been on the market for more than three years. The new review date is March 27, 2024.

FDA Approves Tibsovo for IDH1 Mutated Myelodysplastic Syndromes

Tibsovo is also approved to treat patients with IDH1-mutant acute myeloid leukemia and bile duct cancer.

FDA Approves Byooviz as Interchangeable Lucentis Biosimilar

Byooviz was approved as the first biosimilar to Lucentis and launched with a list price of $1,130 per single-use vial.

Dupixent Gets Complete Response Letter for Inflammatory Skin Disorder

The FDA is requesting additional efficacy data to support an approval for patients with chronic spontaneous urticaria; results of an ongoing study are expected late next year.

FDA Approves First Subcutaneous Infliximab for IBD

FDA Expands Indication of Voxzogo for Young Children with Dwarfism

Voxzogo is now approved for all ages in children with achondroplasia, the most common form of dwarfism.

Phase 3 Trial Shows Significant Weight Loss with Mounjaro

KFF: Premiums for Employer-Sponsored Insurance Increased 7% in 2023

Review: Patients Can Safely Switch to Biosimilars

Researchers in this review suggest clinical trials of biosimilars include switching studies to assess the pharmacokinetics of the biosimilar candidate.

Questions Remain about Nonprescription Opill

Pfizer’s Velsipity Approved for Ulcerative Colitis

Velsipity is the second oral S1P receptor modulator approved by the FDA to treat patients with moderate-to-severe ulcerative colitis. The wholesale acquisition cost is $6,164 for a 30-day supply.

Study Explores Connection Between Adherence and Viral Suppression in Patients with HIV

FDA Issues Complete Response for Alvotech’s Biosimilar of Stelara

The regulatory agency found deficiencies in its inspection of Alvotech’s Reykjavik, Iceland, facility. The company plans to resubmit its application once these are addressed.

FDA Approves Braftovi/Mektovi for Non-Small Cell Lung Cancer

The two-drug regimen of Braftovi and Mektovi was approved to treat patients who have a subset of non-small cell lung cancer, those with a BRAF V600E mutation.

PBM Ventegra Adds Yuflyma Biosimilar as Preferred Product

Court Ruling Takes Aim at Copay Accumulators

Express Scripts Lists Inpefa as Preferred on Medicare Formularies

Cosentyx Approved as an IV Formulation

The IV formulation has a wholesale acquisition cost of $2,115 per vial and will be available in the fourth quarter.