The Colon Cancer Alliance expressed support for the FDA's draft guidance on an improved approval process for biosimilars with a "reference product" already on the market, according to a news release.
The proposed change would expedite the approval process for biological products that are similar to products already approved and on the market. Biological products include vaccines, blood and blood components, gene therapies, tissues and proteins.
"We are encouraged to see the FDA's progress on creating an approval process for biosimilars in the United States, and view the agency's draft guidelines as another important step toward providing a safer, fuller, biosimilars marketplace for American patients," CCA CEO Andrew Spiegel said in the release. "Biologic drugs are crucial for the colorectal cancer community, and biosimilars will allow many patients who suffer from a variety of ailments access to more affordable drugs. But as the FDA moves forward, it must remember that patient safety must come first and foremost, as improperly tested drugs could potentially harm patients."
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The proposed change would expedite the approval process for biological products that are similar to products already approved and on the market. Biological products include vaccines, blood and blood components, gene therapies, tissues and proteins.
"We are encouraged to see the FDA's progress on creating an approval process for biosimilars in the United States, and view the agency's draft guidelines as another important step toward providing a safer, fuller, biosimilars marketplace for American patients," CCA CEO Andrew Spiegel said in the release. "Biologic drugs are crucial for the colorectal cancer community, and biosimilars will allow many patients who suffer from a variety of ailments access to more affordable drugs. But as the FDA moves forward, it must remember that patient safety must come first and foremost, as improperly tested drugs could potentially harm patients."
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5 Quality Mistakes to Avoid With GI Supplies and Equipment
Central Illinois Endoscopy Center Gets 95% Patient Satisfaction Rate
Apollo Endosurgery Raises $47.6M in New Financing