Several cases are pending around the country, but no consensus exists on the circumstances that would require a biosimilar applicant to provide a commercial marketing notice under the Biologics Price Competition and Innovation Act (BPCIA). In light of the implications on the biosimilar’s entry to the market, the courts’ interpretation on whether and when notice is required is of considerable significance to the biologics and biosimilar field.
Excerpted from the Houston Law Review. To read the full article, click here.