ODAC Recommends Approval of First Biosimilar Drug

The Oncologic Drugs Advisory Committee (ODAC) of the Food and Drug Administration (FDA) recommended the approval of the first application for a biosimilar drug on January 7. The panel recommended that FDA approve the application for a biologic agent similar to filgrastim. This drug would be used for a number of applications in hematology.

If FDA follows ODAC’s recommendation and approves the biosimilar, it will be the first biosimilar approved since the FDA received authority to do so as mandated under the Affordable Care Act. Most people are generally familiar with the course of drug development, in which a company has protections for 20 years from the date the patent is filed. After this period has concluded, so-called “generic” drugs become available, usually at much lower prices, typically reducing the cost of care. Because filgrastim is a biologic drug that is built up from living tissue rather than chemical elements, it is impossible to create an identical “generic” drug. For this reason, biosimilars must be examined by the FDA in a separate and different review process.

Generics typically promote competition to the marketplace, helping to bring drug prices down and that the many believe that the establishment of biosimilars will do the same for biologic drugs. However, there are factors that complicate the biologic market enough that prices may not be affected in the same way.

ODAC’s decision was an important step towards the recommendation of approval for additional biosimilar applications. And yet, even before FDA is able to approve this first application, it must determine issues of indication, naming, and product labeling. Furthermore, insurers will need to focus on how to cover biosimilars, including issues such as tiering for cost-sharing. ASH will continue to closely follow and contribute to the issue to ensure that patients have access to safe and effective drugs and therapies at appropriate prices.