The U.S. Food and Drug Administration has scheduled a two-day public hearing on Nov. 2 - 3, 2010, on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009. The hearing will be held from 8:30 a.m. to 4:30 p.m. at the FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31, room 1503, in Silver Spring, Md.
The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to, or interchangeable with, an FDA-licensed biological product.
The purpose of the hearing is to receive input on the act's implementation from the public, health care professionals, health care institutions, manufacturers of biomedical products, industry and professional associations, patients and patient associations, third party payers, and current and prospective biological license application and new drug application holders.
The BPCI Act is consistent with the FDA's policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing.
However, the implementation of an abbreviated approval pathway for biological products can pose scientific and technical challenges associated with the larger molecular structure and manufacturing of biological products. Most are produced in a living system such as a microorganism, plant, or animal cells, while small molecule drugs typically are manufactured through chemical synthesis.
A Federal Register notice, displayed today, outlines specific issues for which the agency is seeking comment. The notice also provides meeting information, instructions for individuals who wish to present at the meeting, and directions for submitting comments.