There are four biosimilars of Stelara available to treat chronic autoimmune diseases — Wezlana, Selarsdi and now Pychiva and Yesintek.
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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.
The PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma is July 10, 2025.
Emblaveo will be available in the third quarter of 2025 to treat patients with intra-abdominal infections, a common cause of sepsis in the intensive care unit.
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Regulators have set a goal of Aug. 12, 2025, for brensocatib to treat patients with non-cystic fibrosis bronchiectasis, a chronic lung disease.
Susvimo is also approved to treat age-related macular degeneration, and the medication, ranibizumab, is delivered though a refillable ocular implant.
The new biosimilar, Celltrion’s Avtozma, was approved in both IV and subcutaneous forms to treat inflammatory conditions such as arthritis.
Chronic kidney disease affects about 37 million adults in the United States and is expected to rise. It is a common complication of type 2 diabetes.
A monthly 10 mg/mL maintenance dose of Leqembi had the same effects on mild Alzheimer’s symptoms as biweekly dose, research shows.
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.
Regulatory officials have identified 82 cases worldwide from the FDA Adverse Event Reporting System of anaphylaxis associated with the use of Coxapone and the generic Glatopa that have resulted in hospitalization or death.
The investigational advanced melanoma combination therapy consisting of RP1 and nivolumab have a PDUFA action date of July 22, 2025.
Trump has reversed some of President Biden’s initiatives, including $2 monthly out-of-pocket cap on some generics and experimental pricing models for gene therapies. But so far the healthcare elements of the Inflation Reduction Act remain unchanged.
Datroway reduced disease progression by 37% when compared with chemotherapy.
CEO Andrew Witty promised that UnitedHealthcare would work to speed up turnaround times for approval of some procedures and services in Medicare Advantage plans.
Ozempic, Rybelsus and Wegovy top the list of the newest drugs selected for Medicare Part D price negotiation, part of the Inflation Reduction Act.
More than half (53%) of patients reached remission after one year of Omvoh treatment and 46% experienced healing of the intestinal tract, when compared to placebo.
In an investor call, Andrew Witty promised full transparency and 100% pass-through rebates for prescription drugs by 2028.
If approved, subcutaneous autoinjector Leqembi will be the only Alzheimer's medication that can be administered at home. The FDA has set a goal date of Aug. 31, 2025.
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