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A federal appeals court ruled Thursday that international versions of Gilead's HIV drug Biktarvy differ materially from FDA-regulated U.S. versions
Gilead $GILD Sciences won a federal appeals court ruling on Thursday upholding a preliminary injunction that blocks several companies from importing its HIV medications through overseas channels and distributing them to U.S. patients via employer health plans, according to CNBC.
The U.S. Court of Appeals found that differences between Gilead's U.S.-market medications and the international versions imported by the defendants were "material, not theoretical," according to CNBC. The court quoted its ruling directly: "What Gilead sells in Turkey and what it sells in Maryland share a chemical formula but materially differ and travel through different quality-control system."
The case centers on alternative funding programs, or AFPs, a category of health plan arrangements that source prescription drugs from international markets. Gilead filed suit in December 2024 against an AFP called Rx Valet and several affiliated companies after a Maryland patient received its HIV drug Biktarvy in the mail from Turkey with label instructions in Turkish.
