, /PRNewswire/ -- According to Pharmaceutical Scientist, Inc., biosimilars are copies of biological drugs introduced after the expiry of the patents or exclusivity of new biological drugs as a more affordable choice for patients. In the US, the legislation has also created an interchangeable class of biosimilars that requires extensive clinical efficacy testing, and the first interchangeable product gets one year of exclusivity.
Developers have used the interchangeable status to claim the superiority of their product despite the FDA warnings in a new guideline that ensures that both classes of biosimilars are equally safe and effective. More significant is the concern that the additional studies are redundant and tantamount to human abuse, as proven by Professor Niazi and later confirmed in the studies conducted by the FDA . But the FDA does not have the right to remove the interchangeable status, so Professor Niazi, who has been advising the FDA for many years, filed a Citizen Petition in 2023 advising the FDA how to go around this problem by allowing interchangeability without requiring additional studies, a decision that the FDA has the right to make, and do it until the US Senate votes on a pending bill presented by Senator Lee, with advice from Professor Niazi, to remove the interchangeable status.
The FDA accepted Professor Niazi's advice and issued a guideline on 20 , allowing developers to claim interchangeability by presenting an argument that the data presented is s.