Having had the opportunity to analyze the biosimilars provisions of the new health care law enacted this past March, stakeholders have at long last the chance on November 2-3 to weigh in on FDA's implementation of the biosimilar approval pathway. FDA will hold a two-day public hearing on November 2-3, 2010, from 8:30 am to 4:30 pm, at the FDA Conference Center on FDA's campus in White Oak, Maryland. FDA published its official announcement of the public hearing in the October 5th issue of the Federal Register. 75 Fed. Reg. 61497 (Oct. 5, 2010).

The Biologics Price Competition and Innovation Act of 2009 (BPCIA), a subtitle of the Patient Protection and Affordable Care Act, creates an abbreviated approval pathway for biological products “highly similar” to a previously approved reference product. The BPCIA also permits FDA to deem as interchangeable a biosimilar that satisfies certain additional specified standards.

FDA now turns its attention to the implementation phase. As FDA acknowledges, implementation of the BPCIA poses significant scientific and technical challenges. Since most biological products are produced in a living system versus through chemical synthesis, their molecular structure and their manufacturing is highly complex.