FDA Pipeline preview, April 2009 (alglucosidase alfa, bosentan, cetuximab, doxepin, telavancin, quetiapine extended-release, oxycodone/niacin, EUR-1073)

Beginning in January 2025, Optum Rx will remove from several Humira biosimilars from its formulary, including Hyrimoz (adalimumab-adaz), the unbranded Hyrimoz and Cyltezo (adalimumab-adbm).

The biggest advantage of suzetrigine would be that it helps patients avoid the use of opioids for acute pain. The FDA’s goal date for suzetrigine is Jan. 30, 2025.

The combination of Columvi, gemcitabine and oxaliplatin is the first CD20xCD3 bispecific antibody to show positive results in a randomized diffuse large B-cell lymphoma phase 3 trial. The FDA’s decision is expected by July 20, 2025.

The FDA has accepted a new drug application for aficamten, a new obstructive hypertrophic cardiomyopathy drug. A goal date has been set for Sept. 26, 2025.

Yesintek is the latest Stelara biosimilar to gain FDA approval and it will be available in February 2025.

If granted, Tremfya will be approved to treat children ages six and under with severe plaque psoriasis and children ages five and under with juvenile psoriatic arthritis.