Sandoz Inc. V. Amgen Inc. Clears The Way For Potential Earlier Launch Of Biosimilars

Sandoz Inc. V. Amgen Inc. Clears The Way For Potential Earlier Launch Of Biosimilars


In Sandoz Inc. v. Amgen Inc. , No. 15-1039 the Supreme Court held that biosimilar applicants may provide the requisite 180-days' notice of commercial marketing to the reference product sponsor even before receiving a license from FDA and that a biosimilar applicant's nondisclosure of its application and manufacturing information cannot be remedied by an injunction under federal law.



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