As we continue to have multiple biosimilar and potential interchangeable approvals for the same reference product, it is important to consider how product drift will impact biosimilar products approved at different times, as well as the characteristics of the biosimilar product itself.Ha Kung Wong (2019). Will product drift cause a rift? PharmaManufacturing
Excellent article on biosimilars and product drift. The rush for biosimilars needs to always remember how biologics are extremely sensitive to changes in the manufacturing process. Biosimilars require the most robust of quality systems and I worry that companies attracted to them for their price savings might cut corners.
A great primer on the topic is: Ramanan, S. & Grampp, G. Drift, Evolution, and Divergence in Biologics and Biosimilars Manufacturing. BioDrugs (2014) 28: 363.
Let’s make sure that we don’t get another Thalidomide, we don’t need other examples for our GxP classes and new employee orientations.
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Thanks for posting this up, BTW!
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