What Does It Mean for a Biosimilar to Be Interchangeable, and Why Is That Important?

Join Tedra Gray, NP, as she dives into what it means for a biosimilar to be interchangeable. Interchangeability is a key designation in the world of biosimilars, ensuring that these medications can be substituted for their reference products at the pharmacy level without the need for prescriber approval. Only a select few biosimilars have earned interchangeability status, meaning they have undergone rigorous FDA evaluation to demonstrate that switching between the biosimilar and the reference product does not compromise safety, efficacy, or patient outcomes. This designation plays a critical role in reducing healthcare costs for both patients and payers by allowing for seamless substitutions when the reference product is unavailable.

To receive FDA approval as an interchangeable biosimilar, manufacturers must conduct extensive clinical studies assessing safety and effectiveness when patients alternate between the reference product and the biosimilar. The results must confirm no loss of effectiveness or increase in safety risks associated with switching. This process ensures that patients receive continuous treatment without unnecessary delays or interruptions in care.

Interchangeable biosimilars are essential in improving access to treatment and managing diseases in a cost-efficient manner. To learn more about biosimilars, interchangeability, and their impact on patient care, visit www.ghapp.org or visit the GHAPP ACE mobile app.