Lexology August 29, 2024
Hogan Lovells

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FTC says FDA’s Draft Guidance on interchangeability will increase competition in biologic marketplaces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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Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
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