After the recent issuing of three final guidance’s by the US FDA, there have been many speculations. Some supporter favor these final documents, while others fear the documents led to the risk of “taking a copycat product.”
There are two main groups that reached out to the commissioner of FDA. These two groups are the Patients for Biology Safety & Access (PBSA) and the Immune Deficiency Foundation (IDF). They want the final guidance’s to focus more on reinforcement safety issues with biosimilar products and not focus on ‘diminishing transparency’.
To read quotes from the letter and learn more about the apprehensions for the guidance’s click here.