FDA shares updated draft guidance on biosim interchangeability

This week, the FDA announced a new draft guidance aimed at providing updated considerations for biosimilar developers on interchangeability study requirements.

The initial 2019 guidance was developed before the FDA had reviewed any biologics license applications for interchangeable biosimilars under section 351(k) of the Public Health Service Act. Since then, the FDA says that data from approved biosimilars have demonstrated that the risks associated with switching between a biosimilar and its reference product, whether once or multiple times, are minimal in terms of safety and efficacy.

The updated, “Considerations for Demonstrating Interchangeability with a Reference Product: Update,” draft guidance suggests that applicants may not always need to conduct extensive switching studies to demonstrate interchangeability. Instead, they can provide a detailed assessment showing that the comparative analytical and clinical data already included in their application or supplement meet the switching standards as specified in section 351(k)(4)(B) of the PHS Act.

The Biosimilars Council, a division of the Association for Accessible Medicines, “applauded” the updated draft guidance, stating that “Biosimilars with and without an interchangeability designation – are safe and effective, and lower price options for patients.” The council also stated that the FDA’s action was consistent with its recommendations.