There have been mixed reviews on the recent publishing of three final guidance’s by the US FDA. Some reviewer’s support the release of these documents, while others fear the documents led to the risk of “taking a copycat product.”
Two main groups that are concerned about these drafts are Patients for Biology Safety & Access (PBSA) and the Immune Deficiency Foundation (IDF). They believe that the guidance’s need to strengthen safety issues with biosimilar products and not focus on ‘diminishing transparency’. These two groups have sent a letter to the commissioner of FDA responding to the release of the guidance. To read quotes from the letter and learn more about the apprehensions for the guidance’s click here.