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.



from Biotech News