A session at ACR Convergence 2024 addressed several recent drug approvals in pediatric rheumatology and a safety update for IL-1/IL-6 inhibitors.
Draft FDA Guidance No Longer Requires Biosimilar Switching Studies
The updated draft guidance, released in June, would accept an assessment of why data provided meet the switching standard to demonstrate interchangeability of biosimilars
FDA Proposal for Biosimilar Use in 2025 Budget
A proposal for biosimilar use in the 2025 budget would allow substitution of any biosimilar for its reference product without an interchangeable designation. The hope is to increase biosimilar uptake, with the subsequent potential to increase product “competition, access and affordability.”1 In the 2025 budget proposal, the Biden administration noted that the legal distinction between…
FDA Grants Interchangeable Designation to Pfizer’s Abrilada, Biosimilar to AbbVie’s Humira
On Oct. 5, Pfizer announced that Abrilada (adalimumab-afzb), its biosimilar to Humira (adalimumab), had received an interchangeable designation from the U.S. Food & Drug Administration (FDA).
FDA Approves First Interchangeable Biosimilar to Adalimumab, Plus a Combination Drug Approved
Cyltezo (adalimumab-adbm) may be interchanged for Humira (adalimumab) for all indications, according to an October decison by the FDA. The FDA has also approved a new combination of celecoxib and tramadol for pain management.
Biosimilars: Still Waiting for Promise to Materialize
During the 2017 ACR/ARHP Annual Meeting, advances in biosimilar treatments were abuzz. However, many speakers noted that the presence of biosimilars on the market has not yet resulted in greater access to treatment and lower drug pricing in the U.S…
Report on EU’s Experience with Biosimilar Drugs Released: Will U.S. Experience Be Similar?
As questions about biosimilar medications swirl among U.S. rheumatologists, a recently released report sheds some light on the European experience with biosimilars—and may offer some important insights for the U.S. market. The report, Biosimilars in the EU: Information Guide for Healthcare Professionals, was released in late April by the European Medicines Agency (EMA) and the…