The Biosimilars Council submitted an amicus brief urging the Supreme Court to permit biosimilar applicants to provide 180-day notice of commercial marketing prior to the FDA’s licensing of their application, instead of waiting until after FDA had licensed their product. On December 14, 2017, the Supreme Court agreed with the Council. This means that an applicant that provides early notice of its intent to commercially market a biosimilar product may be able to launch that product immediately upon receiving FDA approval. This ruling will allow biosimilar products to go to market faster and increase patient access to these life-saving products.
New Blog - Jonathan Kimball gives more detail re: AAM's blueprint & proposed policy framework