'Incorrect' To Assume Interchangeables Are Safer, More Effective Than Biosimilars, Says FDA

Interchangeable biosimilars can be substituted for reference products without the intervention of a prescribing healthcare provider, but that doesn’t imply better safety or effectiveness than other approved biosimilars, a senior regulatory official emphasized at a recent conference in India.

Addressing the BioPharma Conclave 2022, Dr Sarah McMullen, India country director, US Food and Drug Administration, underscored that there’s no real distinction in the standards to determine the safety or efficacy for both biosimilars and interchangeable biosimilars, and put forth a “fact check” to dispel the