Although biosimilar drugs have been much slower to take off in the US than they have been in the EU, the FDA recognizes the important role these products can play in potentially cutting healthcare costs in the US. The agency is making efforts to both encourage the development of biosimilar drugs and streamline the FDA review and approval process.
However, the FDA understands that simply getting these products to market is not enough. To ensure drug acceptance and uptake, there also must be efforts made to educate physicians on what these drugs are and how they can help patients.
In light of this, FDA commissioner, Scott Gottlieb, recently announced that the agency has launched an educational campaign to ensure that healthcare providers are adequately informed about biosimilar products. According to Gottlieb’s blog post, the FDA conducted research into the specific areas that providers have questions about, and used this insight to develop targeted educational materials. The materials can be found on the Biosimilars page on the FDA website and provide the following:
- Basic biosimilar product information, including definitions of terms commonly used in the biosimilar space, such as reference product, interchangeability, biosimilarity, Purple Book, etc.
- An overview of the approval pathway for biosimilar products
- Information on the data and materials required by the FDA to assess safety and efficacy prior to approval
- An overview of the Purple Book, an important reference which allows healthcare providers to find out which biological reference products have an approved biosimilar or interchangeable product approved by the FDA
- Information on the data and materials required by the FDA to determine biosimilarity to a reference product
According to Gottlieb, the next step for the FDA will be to research what information patients need to know most in order to fully understand the potential role biosimilar products can play in their healthcare plans. This will help the FDA plan future measures to facilitate the successful dissemination of information from physicians to their patients.