Lupus nephritis is one of the leading causes of mortality for patients with systemic lupus erythematosus (SLE), and patients with both SLE and end-stage renal disease have standardized mortality ratios more than 60 times that of patients with SLE with normal kidney function.1 The good news: Rheumatologists now have not one, but two approved options…
In late July 2022, the U.S. Food & Drug Administration (FDA) approved belimumab (Benlysta) for the treatment of children with active lupus nephritis aged 5 to 17 years old receiving standard therapy.1 Despite recent advances in treatment options for patients with systemic lupus erythematosus (SLE), those with kidney involvement may develop endstage renal disease and…
The FDA as approved the biosimilar treatments denosumab-nxxp (Bildyos) and denosumab-nxxp (Bilprevda) for all indications of denosumab, their reference product, including osteoporosis in postmenopausal women.
The FDA has approved a new drug application for TNX-102 SL (Tonmya), a tablet with 2.8 mg of cyclobenzaprine HCl, after two clinical trials demonstrated the safety and effectiveness of the treatment in adults with fibromyalgia.
Ustekinumab-stba (Steqeyma) now has FDA approval for all forms and dosages of its reference product, ustekinumab (Stelara), including a subcutaneous injection to treat pediatric patients with plaque psoriasis or psoriatic arthritis.
Here is a brief recap of the latest FDA-approved biosimilar agents, highlighting their reference products and interchangeability.
Supported by data in patients with new-onset and relapsing giant cell arteritis (GCA), the FDA approved upadacitinib for the treatment of adults with GCA.
Based on research in post-surgery patients, the FDA approved suzetrigine, a non-opioid analgesic, for the treatment moderate to severe, acute pain in adults.
The FDA is reviewing supplemental biologics license applications for guselkumab to treat children with juvenile psoriatic arthritis and moderate to severe plaque psoriasis.
The FDA has approved bimekizumab-bkzx for the treatment of adults with psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.