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The following message was posted to: PharmPK
We are currently involved in planning bioanalytical PK ELISA method development, validation and clinical sample analysis for a biosimilar biologic along with the innovator product arm.
I am having the following observation at lab during method development and would like to know your thoughts/inputs.....
We are having difficulty in successfully recovering (80%-120%) Innovator Quality control samples (QCs), using calibration curve made with the Biosimilar drug, indicating lack of robustness.
However, Innovator QCs can be robustly recovered using calibration curve made with the Innovator drug,
The same is true for the biosimilar, whose QCs can be robustly recovered using calibration curve made with biosimilar drug
I do not think this is an issue with the critical reagents as the respective drug's QCs can be successfully & robustly recovered using respective drug's cal curve.
Can I plan for two separate validations, where respective drugs will be used to make respective QCs....will the regulators be okay with it?
Thinking ahead ...
Do you think that it is possible to segregate blinded clinical trial samples according to biosimilar and innovator arms, and let just the arm name be shared with the CRO , so that the respective drug's calibrator curve and QCs can be loaded on sample analysis plates.
Finally, does this observation implicate anything regarding the biosimilarity quotient of the drug towards the innovator or it is just an observation and better not to over interpret it..
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Hm: Seems like the biosimilar may not be so biosimilar. This indicates a difference between the two products (glycosylation). Since you have seen this difference might there may be others (antigenicity) that are related to the difference?
Are the components of the assay-capture and detect entities derived from the biosimilar or from the innovator?
What is the structure of the assay-displacement or sandwich?
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