Supreme Court Rules Biosimilars Don’t Have To Wait 6 Months Post FDA Approval

The Supreme Court has handed down a ruling that will make it easier for biosimilar drugs to hit the US market. On Monday, the Supreme Court unanimously ruled that biosimilar companies no longer have to wait an extra six months after FDA approval before launching their drugs for the market. The case, which was between biologics producer Amgen and biosimilar producer Sandoz, attempted to clarify the “patent dance” process. During this process, the biosimilar producer and the company that produces the reference product must exchange information and determine the patent situation of the drugs before the biosimilar can hit the market.

Amgen, which produces biologics, argued that biosimilar companies should have to wait six months after FDA approval before launching their products. However, Sandoz argued that doing so would effectively give Amgen an effective six month exclusivity period. After receiving the favorable ruling, Carol Lynch, Sandoz’s global head of biopharmaceuticals, released a statement to Focus. “The Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments. We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward,” she said.

The Supreme Court did leave the question of whether “it is enforceable by an injunction under federal or state law” that a biosimilar applicant must provide the biologic reference product sponsor with its application and manufacturing information up to the states. The opinion states “There is no dispute about how the federal scheme actually works, and thus nothing for us to decide as a matter of federal law. The mandatory or conditional nature of the BPCIA’s [Biologics Price Competition and Innovation Act, which established the pathway by which biosimilars are approved] requirements matters only for purposes of California’s unfair competition law, which penalizes ‘unlawful’ conduct. Whether Sandoz’s conduct was ‘unlawful’ under the unfair competition law is a state-law question, and the court below erred in attempting to answer that question by referring to the BPCIA alone.”

Legal analysts believe that the FDA could get further involved in the patent dance process and in the interpretation of BPCIA regulations. FDA and regulatory law firms are likely to be working with biosimilar and biologic companies to determine how the clarification of the law will affect them.





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