The FDA has issued draft guidance recommending that all biosimilar medications be designated as interchangeable with their reference products upon initial FDA approval. A 60-day review and comment period of the draft guidance is now open, and the ACR will soon be submitting comments.
FDA Approves 2 More Denosumab Biosimilars
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.
FDA Approves Ustekinumab-stba for All Forms & Dosages as Its Reference Product
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.
Underwater Biosimilars Coalition Shares Results of Practice Survey with Congressional Leaders
This week, the Coalition sent Congressional leadership a letter detailing the results of a recent survey about how underwater biosimilars are impacting physicians’ ability to provide high-quality care. Almost all of the nearly 200 practices queried reported being underwater on several biosimilars, with rituximab and infliximab biosimilars being the most common.
Colin Edgerton, MD, Testifies in Congressional Hearing on Biosimilars
In front of the U.S. House Ways and Means Subcommittee, Dr. Edgerton described how challenges of biosimilar costs threaten patient care and outlined several potential legislative solutions.
March Updates from the ACR Insurance Subcommittee
The Insurance Subcommittee is working on behalf of ACR members to address underwater formulary requirements for biosimilars, mandated switches to biosimilars, evaluation and management downcoding and more.
Reproductive Health, Biosimilars & More in Focus at SOTA 2025
Reproductive health, biosimilars, IgG4-related disease and much more—five speakers give us a sneak peek into important topics being addressed at the ACR’s 2025 State-of-the-Art Clinical Symposium, April 4–6.
The Ethical Tug-of-War Over Biosimilar Adoption
The advent of biosimilar medications has offered the promise of significant cost savings for healthcare systems and patients. Biosimilars are highly similar versions of existing biologic drugs, providing a more affordable alternative once the original biologic patent expires. However, the adoption of biosimilars in the U.S. has been hampered by myriad roadblocks, many of which…
FDA Officials Discuss Extrapolation & Confusion Around Pediatric Therapies
A session at ACR Convergence 2024 addressed several recent drug approvals in pediatric rheumatology and a safety update for IL-1/IL-6 inhibitors.
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