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.
Biosimilar Update: 2025 Brings More FDA Approvals & Interchangeability
Here is a brief recap of the latest FDA-approved biosimilar agents, highlighting their reference products and interchangeability.
FDA Approves Upadacitinib for GCA
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.
FDA Approvals: Lupus Nephritis
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…
Belimumab Promising for Children with Lupus Nephritis
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…
FDA Approves Suzetrigine (VX-548), a Non-Opioid Analgesic
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.
FDA Approval Sought for 2 Pediatric Indications for Guselkumab
The FDA is reviewing supplemental biologics license applications for guselkumab to treat children with juvenile psoriatic arthritis and moderate to severe plaque psoriasis.
FDA Approves Bimekizumab-bkzx (Bimzelx) for 3 New Rheumatic Indications
The FDA has approved bimekizumab-bkzx for the treatment of adults with psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.
FDA Approves 2 Upadacitinib Formulations for Children with pJIA & PsA
Upadacitinib, as a tablet and oral solution, is now FDA approved to treat children age 2 years and older with active polyarticular juvenile idiopathic arthritis or psoriatic arthritis.
FDA Approves Sarilumab for pJIA
The FDA has granted sarilumab its first pediatric indication, approving the agent to treat active, polyarticular juvenile idiopathic arthritis (pJIA) in patients who weigh at least 63 kgs.
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