On June 12, 2017, the U.S. Supreme Court issued its decision in Amgen Inc. v. Sandoz Inc., a case surrounding biosimilars and the interpretation of certain provisions under the Biologics Price Competition and Innovation Act (BPCIA). The decision reversed the Federal Circuit's ruling and concluded that biosimilar makers need not wait for approval before supplying 180-day notice of sales under the BPCIA. The Supreme Court also asked the Federal Circuit to decide whether state law is preempted by the BPCIA. Law360 contacted Finnegan partner Sanya Sukduang for his thoughts on the decision.
He said, "What [the question of whether state law is preempted] does is potentially give rise to different decisions on the disclosure issue, depending on the state that you're in." When asked whether he thinks the Food and Drug Administration (FDA) will intervene and provide its own interpretation of the BPCIA, Sukduang said, "The FDA for years has been saying ... that they don't want to be involved in that—that their job is determining safety and efficacy."
Tags
Amgen Inc. v. Sandoz Inc., Biologics Price Competition and Innovation Act (BPCIA), Supreme Court of the United States (SCOTUS)