State Biosimilar Bills Pose New Threat to Budding Industry
- Jeff Overley
- IP Law360
Timothy J. Shea, Jr. was quoted in an article that recently appeared in IP Law360. The article, entitled "State Biosimilar Bills Pose New Threat To Budding Industry", discusses proposed restrictions to patient access to generic medicine. Opponents of the state-level regulations claim that restrictions will harm the biosimilars industry and infringe upon federal regulations. The proposed bills would require pharmacists to notify doctors of substitutions, receive written consent from patients, and keep records of substitutions.
In response to the notification and consent requirements, Mr. Shea explained that the bills leave the false impression that substitutions for biosimilars are risky. "Anything that raises the specter that this product is not the same as the brand product, and moves you further away from the ease we see with generic drugs being substituted, can be an impediment," Mr. Shea said.
Subscribers of Law360 can access the full article here.