FDA Issues Final Guidance on Pathway for Interchangeable Biologics – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
In an effort to promote competition in the biologic market, officials with the FDA today released a final guidance on the pathway for interchangeable biosimilar products.
According to a statement released by acting FDA Commissioner Ned Sharpless, MD, the final guidance will provide clarity for developers who want to demonstrate that their proposed biological products meet the statutory interchangeability standard under the Public Health Service Act. Ultimately, the goal is to help patients by making more treatment options available.