U.S. Physicians Back FDA Standards for Biosimilars in 2024
- A survey of 270 U.S. physicians found that 88% support the FDA's current data standards for interchangeable biosimilars.
- The majority of physicians believe that rigorous evaluations are necessary for biosimilars to be considered interchangeable.
- The findings indicate a strong preference for maintaining high safety standards to ensure patient treatment stability.
A recent survey conducted in August 2024 among 270 U.S. physicians revealed overwhelming support for the FDA's current data standards for interchangeable biosimilars. The survey, commissioned by the Alliance for Safe Biologic Medicines, included specialists from various fields such as gastroenterology and oncology. A significant 88% of physicians expressed that switching studies enhance their confidence in the safety of transitioning patients from originator medicines to interchangeable biosimilars. Furthermore, 87% indicated a preference for switching only if rigorous evaluations of safety and efficacy were conducted. The survey highlighted that 85% of respondents believe that biosimilars should only be considered interchangeable if they have undergone specific assessments for safety and efficacy in switching scenarios. This reflects a broader concern among physicians regarding pharmacy substitution of non-interchangeable biosimilars, which is viewed as potentially disruptive to patient treatment stability. The findings align with previous surveys indicating that a majority of physicians prefer that the decision on which biologic to use remains between the physician and patient, rather than being influenced by third parties like pharmacies or insurance companies. The results were shared with the FDA during a public comment period on draft guidance that proposes to lower data requirements for demonstrating interchangeability. Additionally, the U.S. Senate is contemplating legislation that would classify all biosimilars as interchangeable, which could undermine the rigorous standards currently in place. The Alliance for Safe Biologic Medicines emphasizes that maintaining these standards is crucial for ensuring patient safety and preserving physician confidence in biosimilars. In conclusion, the survey underscores the medical community's commitment to patient-centered care and the importance of rigorous evaluation processes for biosimilars. The potential legislative changes could significantly impact the landscape of biologic medicine, making it imperative for stakeholders to advocate for maintaining high safety and efficacy standards.