By Julian Pecquet - 10/04/10 02:41 PM EDT
The Food and Drug Administration on Monday announced that it is holding a two-day public hearing as it prepares to develop regulations for the approval of generic versions of biological products. The hearing will be Nov. 2 and Nov. 3 at the FDA's White Oak campus in Silver Spring, Md.
One of the provisions of the new healthcare reform law allows for the approval of generic versions of biologics — also known as biosimilars — after 12 years of data exclusivity. Biologics refers to medications and other medical products created through biological processes rather than chemistry.
The Biologics Price Competition and Innovation 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," FDA said in a statement. "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."
The FDA will be seeking input from stakeholders and the public on a variety of issues, including:
_ Scientific and technical factors related to a determination of biosimilarity or interchangeability;
_ The kinds of safeguards the agency should consider to assist the healthcare community when prescribing, administering, and dispensing biological products to prevent unsafe substitution of biological products; and
_ the establishment of a user fee program for biosimilar and interchangeable biological products.
Correction: The new law allows for 12 years of data exclusivity, not patent exclusivity as originally reported.