Rachel Sherman, Associate Director for Medical Policy, within CDER gave an update on biosimilars today. Protein biosimilars (but not chemically synthesized polypeptides) will be regulated under Public Health Services Act section 351.
The 351 (k) approval route will require the FDA to consider:
- Analytical studies to show th ebiosimilar is highly similar to the reference product
- animal studies (including toxicology) as needed
- clinical studies to establish safety, purity and potency in one or more conditions of use for the reference product
To assess biosimilarity, Sherman explained that each study adds a piece of information to understand what a biosimilar product is and is not, and what other information is needed. The FDA may also adopt the European approach to "use the totality of the evidence" to address biosimilarity.
To date, there have been 35 Pre-IND meeting requests for proposed biosimilars to 11 reference products, 21 Pre-IND meetings held and 9 INDs received at FDA. The line is rapidly forming.
FDA guidance has not appeared as yet, and is still in "final stages" at the agency. No timeline for publication has been issued.
Posted by Bruce Lehr Feb 3rd 2012.