The Act created an abbreviated licensure pathway for biological products in the part of the law known as the Biologics Price Competition and Innovation Act. Under the BPCI Act, a biological product may be demonstrated to be "biosimilar" if data shows that, among other things, the product is "highly similar" to an already approved biological product.
To read the entirety of the article, please visit the Genetic Engineering & Biotechnology News website.
Vincent Capuano and Anthony Fitzpatrick are partners in the Intellectual Property Practice Group in the firm's Boston office.