Scientists at the FDA have provided their recommendation to be submitted to an independent medical advisory panel that will decide the fate of Remsima.
The market value of Remicade, Enbrel, and Humira could dwindle if Celltrion’s biosimilar to Remicade—deemed “highly similar” to the reference product by the FDA—is approved.
According to a news report by Reuters, scientists at the FDA provided their recommendation to be submitted to an independent medical advisory panel that will decide the fate of Remsima for rheumatoid arthritis and inflammatory bowel conditions like Crohn’s disease. The panel will recommend, or not, the biosimilar developed through a collaboration between Pfizer and Celltrion.
The scientists state in their report that Remsima is highly similar to Remicade in treating rheumatoid arthritis and ankylosing spondylitis, and that there are only minor differences in clinically inactive components.
If approved, this will be just the second biosimilar to enter the market after Zarxio, which was approved late last year. While a lot remains unknown in the field—naming, physician awareness, reimbursement policies for the follow-on biological—there’s definitely no turning back.
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April 23rd 2024New health privacy rules aim to protect patients and providers in an evolving abortion landscape; some physicians express concerns about efficacy, risks, and entrenched beliefs in treating Alzheimer disease; CMS addresses longstanding staffing deficits in nursing homes.
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The Biden administration recently launched the Global Health Security Strategy, a new effort to combat the spread of infectious diseases; lawmakers zeroed in on the risks of massive consolidation in health care during the first congressional hearing on the Change Healthcare hack; the FDA recently announced the recall of a pair of heart devices linked to numerous deaths and injuries.
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