Sandoz Inc. v. Amgen Inc.

Background

A major drugmaker that sells a licensed biologic and a company seeking to sell a biosimilar clashed over rules in a federal law called the BPCIA. The biosimilar maker filed for FDA approval but declined to give the other company its application and manufacturing information. It also gave notice of intent to market before the FDA formally licensed the product. The drugmaker sued in federal court and also relied on California business-law claims seeking injunctions to force disclosure and to block early notice-based marketing.

Reasoning

The Court answered two questions. First, it held that federal law does not authorize a federal court to issue an injunction forcing an applicant to provide its FDA application and manufacturing information, because the BPCIA provides a specific federal remedy that displaces broader federal injunctions. The Court remanded the state-law claim so a lower court can decide whether state business law treats the refusal to disclose as unlawful and whether any state remedy is pre‑empted. Second, the Court held that the law allows an applicant to give the 180‑day marketing notice before FDA licensure, so prelicensure notice is effective and a federal injunction blocking marketing until 180 days after licensure was improper.

Real world impact

Biosimilar applicants can give their 180‑day marketing notice before FDA approval, changing marketing timing. Federal courts cannot force disclosure of application files, but state courts may still decide on state-law injunctions. The decision shifts some disputes to state law and affects how and when biosimilars enter the market.

Dissents or concurrances

Justice Breyer concurred, noting the FDA might later adopt a different interpretation based on administrative experience.