Biosimilars in the United States: Current Status and Future Implications
A primer for U.S. physicians on the role of biosimilars in medical treatment.
Yuflyma becomes fourth Humira biosimilar to receive interchangeability status
The FDA has accepted Yuflyma as an interchangeable biosimilar to adalimumab for the treatment of multiple chronic inflammatory diseases, Celltrion USA announced in a press release.
FDA grants approval to two more denosumab biosimilars
The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, according to an industry press release.
Two new denosumab biosimilars earn FDA approval
The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, according to a press release from Celltrion.
First four Stelara biosimilars launch in US; ‘white labeling’ threatens market ‘vibrancy’
Four biosimilars for Stelara have launched in the United States this year following legal settlements with the reference product manufacturer, Janssen Pharmaceuticals, which set timelines for their market entries.
FDA approves two new biosimilars of denosumab
The FDA has approved two new biosimilars of denosumab to treat osteoporosis, increase bone mass, prevent skeletal-related events for people with multiple myeloma and other indications, Samsung Bioepis announced.
FDA approves third Actemra biosimilar; second available in intravenous, subcutaneous forms
The FDA has approved a third biosimilar for tocilizumab, called Avtozma, the second such biosimilar to be available in both intravenous and subcutaneous formulations, according to a press release.
ACR urges congressional leaders to reform ‘underwater’ biosimilar reimbursement
The American College of Rheumatology has joined a coalition of more than 40 other organizations calling on congressional leaders to address what they see as insufficient Medicare reimbursements for biosimilars.
FDA approves Yesintek, sixth Stelara biosimilar; launch slated for February
The FDA has approved the Stelara biosimilar Yesintek for indications matching the reference product, with a commercial launch date expected for early 2025, according to a press release from Biocon Biologics.
Practice-level policies ‘likely key drivers’ of infliximab biosimilar uptake
WASHINGTON — Biosimilar infliximab use is significantly more common among new users vs. those who started with the originator, and particularly less likely among Medicare beneficiaries, according to data presented at ACR Convergence 2024.
EHR can help automate biosimilar selection, streamline prior authorization
An electronic health record tool has demonstrated the potential to automate the selection of biosimilars.