Lexology August 29, 2024
This is the fourth comment related to the pharmaceutical industry the FTC has submitted to various agencies since the beginning of 2024, and part of a broader effort by the FTC to prioritize “safeguarding fair competition and rooting out unlawful business practices in health care markets.”[1]
FTC says FDA’s Draft Guidance on interchangeability will increase competition in biologic marketplaces
Under the Public Health Service Act, the standard for interchangeability is that a biosimilar “can be expected to produce the same clinical result as the reference product in any given patient.”[2] For a product that is administered more than once to a patient, this means that the “risk in terms of safety or diminished efficacy of alternating or switching between use...
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