Official announcements from pharmaceutical companies or FDA approval database

FTC Supports FDA Proposal for Easier Biosimilar Market Entry

Aug 20, 2024, 06:31 PM

The Federal Trade Commission (FTC) has expressed support for a proposed guidance by the U.S. Food and Drug Administration (FDA) aimed at facilitating the market entry of biosimilar drugs. This proposal is designed to make it easier for drugmakers to demonstrate that biosimilar medicines are safe and effective substitutes for more expensive brand-name drugs. Biosimilars offer patients access to life-saving medications at more affordable prices, potentially impacting the pharmaceutical market significantly. The FTC's backing highlights the economic considerations and antitrust implications of biosimilar market entry, which are comparable to those of generic drugs. The proposal could streamline the approval process, enhancing competition and reducing healthcare costs.