Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed; Draft Guidance for Industry; Availability

The Association for Accessible Medicines (AAM), and its Biosimilars Council (collectively referred to in these comments as AAM), are pleased to submit comments supporting the draft guidance FDA-2019-D-5270-0002 that addresses Food and Drug Administration (FDA) recommendations to applicants seeking licensure under the Public Health Service Act (the PHS Act) of a proposed biosimilar or proposed interchangeable biologic for fewer than all of the reference product's licensed conditions of use. Please find our full comments enclosed.