In a recent article at ASCO, a group of oncologists have weighed in on the prospect of biosimalrs and what they could do for treating cancer. A recent white paper released by The National Comprehensive Cancer Network (NCCN) has stated they will support the use of biosimilars as it will be a critical cost saver for both the patients and society as a whole. With the promised guidelines from the FDA, many oncologists believe that it is important for the biosimilars to go through clinical trials as the manufacturing process will be different, as that does cause difference to come about in the body's response to the medication. They may exercise caution should they believe biosimilars have not gone through the right approval process.
Dr. Gary Lyman believes that companies need to show complete interchangeability between biosimilars and biologics before the drugs are used, though:
“Whether companies will be required to show comparability or true interchangeability remains to be seen,” Dr. Lyman said. Pharmacokinetic equivalence does not ensure comparability, and interchangeability is an even more stringent requirement, mandating that the new agent provide the same clinical result in any given patient. “Clearly,” he noted, “this is a high bar.”
Do you think doctors will fully embrace biosimilars once they have an approval process from the FDA? What are some of the things that could cause setbacks in their use from those in the medical field?
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