Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with a left ventricular ejection fraction (LVEF) of ≥40%.
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Steqeyma is one of seven Stelara biosimilars that have been approved by the FDA.
Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
The new bill would also require state Medicaid programs to report National Average Drug Acquisition Costs (NADAC) as a way to increase transparency in drug pricing.
Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce the risk of stroke and deep vein thrombosis.
Celltrion’s Omlyclo is interchangeable with Xolair to treat the same conditions: asthma, chronic rhinosinusitis, food allergy and chronic spontaneous urticaria.
Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
NovoCare Pharmacy will provide all dose strengths of Wegovy at a reduced cost of $499 per month for cash-paying patients without insurance.
The FDA has accepted Amneal’s biologics licensing application for two biosimilars referencing Prolia and Xgeva.
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The FDA had approved Otulfi in September 2024 to treat Crohn’s disease, ulcerative colitis, psoriasis and active psoriatic arthritis. Information on pricing is not yet available.
The Institute for Clinical and Economic Review has prepared a special report on Trelegy and Breo, two therapies that treat patients with chronic obstructive pulmonary disease that are part of CMS's drug price negotiation program.
Selarsdi and Yesintek have launched this month at prices that are 85% and 90% off the cost of Stelara.
Blue Cross Blue Shield of Michigan said it is evaluating any potential updates to the coverage process for Darzalex Faspro and there are no changes at this time.
This once-daily topical treatment is the latest phosphodiesterase-4 (PDE4) inhibitor designed for mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years. The PDUFA target action date of October 13, 2025, is set for its decision on the application.
The FDA has accepted the biologics licensing application (BLA) resubmission for odronextamab, a potential treatment for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.
At what was supposed to be a hearing to discuss PBM reform, some in Congress veered off into discussions about Medicaid and maternal health, and even Elon Musk.
The new lower prices apply to some doses of Zepbound provided in vials but not the autoinjector pens.
There are four biosimilars of Stelara available to treat chronic autoimmune diseases — Wezlana, Selarsdi and now Pychiva and Yesintek.
Teva and Alvotech are introducing Selarsdi at an 85% discount off the reference product Stelara. Selarsdi is available as a subcutaneous injection and for intravenous infusion.
Merilog is expected to be available in July 2025, and Sanofi will provide Merilog to patients for $35 or less for a 30-day supply.
So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval for its biosimilar to be completed in the fourth quarter of 2025.
Samsung Bioepis’ biosimilars Ospomyv and Xbryk have been approved to be interchangeable with Prolia/Xgeva treat osteoporosis and multiple myeloma/bone metastases from solid tumors.
Gomekli is the second ever FDA-approved treatment for rare tumor disease, NF1-PN and the first to be approved for both adult and pediatric patients.
The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic atrophy secondary to age-related macular degeneration.
Just as Andrew Witty of UnitedHealth Group did in a call with investors last month, CVS Health’s CEO David Joyner defended the role of PBMs in healthcare.
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