Biologics include a wide variety of products including vaccines, blood and blood components, gene therapies, tissues, and protein used to treat diseases and health conditions. Unlike most prescription drugs made through chemical processes, biological products generally are made from human and/or animal materials. In a sense they are natural products with defined biological role. A biological product may be demonstrated to be “biosimilar” if scientc data suppport that the product is “highly similar” to an already-approved biological product. Can we assume that biologics used for therapeutic purposes would behave in same way as they would do so in healthy individuals? If scientific dada demonstrate that they are 'biosimilar' to reference product (even after being manufactured from different sources by different pathways) - how much 'similar' they will be in true sense? What will be be right ways to ensure their safety?
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
Dear Bhushan Patwardhan,
Interesting question. I would regard a biosimilar as a molecule requiring extensive tests, not to the level of a novel drug, but clearly all safety and efficacy aspects should be evaluated experimentally and clinically. We all know that a single point mutation can alter the function of a protein drastically. Need not be a mutation in the binding site - there are many examples on that framework mutations and other distant modifications/mutations may alter the function, at least in the area I work (molecular interactions).
So all in all I think that the word biosimilar is a very good description - it is similar, but since it is not identical one have to find out efficacy/potency/safety/... for each and every case.
Best regards,
Karl
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