The US FTC and the FDA issue a joint statement and plan seeking to advance biosimilar competition and combat deceptive and anticompetitive practices in the biologic marketplace

On February 3, 2020, the Federal Trade Commission ("FTC") and the Food and Drug Administration ("FDA") issued a joint statement and plan seeking to advance biosimilar competition and combat deceptive and anticompetitive practices in the "biologic marketplace." As discussed below, the FTC and FDA are targeting a broad range of conduct, including alleged restrictions on access to biologic drug samples, false and misleading marketing practices, and certain patent litigation settlements between biologic and biosimilar drug manufacturers. Background A biologic drug is generally a pharmaceutical whose active ingredient is a large, complex molecule that is produced using biotechnology in a living system, such as a microorganism, plant cell, or animal cell. [1] "The nature of biological

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  • White & Case (Washington)
  • White & Case (Washington)

Quotation

Adam Acosta, Eric Grannon, The US FTC and the FDA issue a joint statement and plan seeking to advance biosimilar competition and combat deceptive and anticompetitive practices in the biologic marketplace, 3 February 2020, e-Competitions February 2020, Art. N° 93558

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