November 17th, 2014
The Biosimilars Price Competition and Innovation Act of 2009 (BPCIA) introduced a long-awaited, and highly-supported, abbreviated route to market for “biosimilar” and “interchangeable” biologic products. The goal was to create incentives for development and reduce health care costs in the same way that previous legislation had accomplished in the generic arena over three decades ago.
However, widespread criticism of BPCIA provisions to facilitate interactions between biosimilar applicants and reference biologic sponsors regarding application submission and patent status was swift and unrelenting. Attorneys practicing in the realm of Hatch-Waxman litigation for generic drugs balked at the drastic differences between the familiar public process grounded in required patent disclosures, FDA Orange Book listings, and generic applicant certifications and the private, iterative process set forth in the BPCIA. Legal scholars, industry representatives, and practitioners alike projected that a courtroom battle regarding real-world operation of the provisions was imminent.Read the rest of this entry »