The standard Generic Drugs are chemically synthesized but Biologics (Biosimilars) are made by cells and are subject to variability in their structure and function. Biosimilars per the FDA are “biological prescription drugs that are demonstrated to be “highly similar” (biosimilar) to or “interchangeable” with an FDA-approved biological product.” See more information on Biosimilars at http://www.fda.gov
The approval pathway for Biosimilars is via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This Act establishes an abbreviated approval pathway for biological products that are demonstrated to be Biosimilar. Go to http://www.fda.gov to view the Act
The significant advantage for patients using Biosimilars is the price reduction. Of course, in my opinion the interchangeability is a concern. I do not want to give up quality, efficacy and safety for a lower price; guidelines from the FDA with regard to testing will be extremely important. One of the advantages for the company that originally developed the Biologic is the market exclusivity thus, patent protection but also a series of legal events that can be utilized. I think an immediate financial advantage for the company that filed the BLA would also be an extra incentive to help reduce market barriers for the bio-generic company
In my opinion the future of Biosimilars is quite promising. The FDA recently had a two-day public hearing to solicit comments regarding the issues and challenges associated with getting Biosimilars on the market. I am hopeful that the FDA’s office for Biosimilars will work in a timely manner to put the necessary guidelines and procedures in place for bio-genetics companies to follow specifically, with regard to testing. My hope is that the FDA will see the development of generic biologics as opportunities not obstacles. Lastly, I hope the FDA will proceed beyond their two-day meeting.
My Perspective - Kathryn Davis 