The reliable bridging of data derived from studies with a non-EU or non-US licensed product to the respective licensed reference product remains challenging. This has been followed in the May 2013 drafted revision of EMA’s Overarching guideline. As is stated in the response to Question 4 of the Q&A document of EMA [ 19 ], a close collaboration with FDA is foreseen in the upcoming revision of the biosimilar guideline CHMP/437/04 to ensure harmonization of requirements of reference products for the comparability exercise. It should be noted that bridging data between studies gathered by the use of different reference products may result in potential bias regarding safety data.
PLEASE READ THIS: I became very sick consuming 3 glasses of bone broth per day for around a year. Not just physically sick but terrible depression, anxiety, suicidal thoughts since I couldn’t go on this way. I stopped bone broth, and got better overnight. Interestingly though, I had a hair tissue analysis, and the results showed tin which was off the chart and copper toxicity which was 75% as high as the tin, not lead. Please note that I cant give any advice as I’m not a health professional – just warn of my own experience, which has significantly damaged my life. couldnt work and am now unemployed, tried to plead with my doctor who thinks I must have psych problems since its not something he recognises.