By Sheila Magil (smagilbptccom)
The biopharmaceutical industry has been waiting for guidance from the FDA on the approval process for biosimilars since the EMA published its Guideline on Biosimilar Biological Medicinal Products in 2005. Through the enactment of the Biologics Price Competition and Innovation Act of 2009, Congress directed the FDA to develop a process for approval of biosimilars. However, the Agency still has yet to publish a guideline for biosimilar approval.
Kozlowski S, et al offer a hint as to what the published pathway may look like in a recent article titled, “Developing the Nation’s Biosimilars Program,” published in the August 4th issue of the New England Journal of Medicine. Alluding to the EMA experience with approval of biosimilars, the article suggests that a “one size fits all” approach is not likely and that the FDA is unlikely to sign off on a biosimilars route that eliminates the requirement for animal and possibly human studies. It is also doubtful that the Agency will answer questions about the need for these studies without first reviewing the characterization and in vitro data for the proposed biosimilar. What the FDA appears to propose is a stronger Agency-sponsor interaction to identify any necessary animal or human testing and that the decisions will be risk-based and built on the understanding of the underlying mechanism of action. The greater the body of knowledge, the more readily the risk can be evaluated from characterization data alone.
In the end the expectation is that a biosimilar submission will have to include more than simple analytical characterization comparisons. It remains to be seen whether the effort required to gain approval for a biosimilar is reduced sufficiently to support this approach or whether it is more rational to develop a “biobetter” and have 12 years of market exclusivity.