WASHINGTON—Colon Cancer Alliance CEO Andrew Spiegel this week showed support for the Food and Drug Administration's (FDA) draft guidelines for an American biosimilars approval pathway. He issued the following statement:
"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," Spiegel said. "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."
Spiegel also urged the agency to continue working with various stakeholders as it continues in the process of designing an approval pathway.
"We hope the FDA will remain open to input from the Colon Cancer Alliance and other patient-advocacy groups as they continue the process of creating a biosimilars approval pathway," he said. "This will help ensure the final process best reflects the needs of all Americans who need safe, effective, biosimilars drugs."
Last week, the FDA released its long-awaited draft guidelines on an American biosimilars approval pathway. Biosimilars are similar to, but not the same as, innovator biologic medicines. Biologics are made from living organisms and have proven to treat a variety of ailments—including cancer—more effectively than chemically based drugs, according to the CCA.
The Colon Cancer Alliance (CCA) is a colorectal-cancer patient-advocacy organization which provides support patients, screening, access, awareness, advocacy and research.