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WASHINGTON — The FDA on Friday spelled out exactly what kind of studies biosimilar drug makers must conduct in order to be considered “interchangeable” with a biologic drug the way a generic functions for a normal medicine.

It’s the agency’s final word on a controversial and long-running fight over how it will define those rules for the pricey category of biologic drugs, the complex drugs made from living organisms used to treat conditions like cancer, and their copycat biosimilars.


Biosimilars have been held up by supporters as a market-friendly way to drive down the cost of some of the world’s most expensive drugs. And advocates for the nascent industry have long been calling for Friday’s policy because, they argue, more “interchangeable” drugs — and more certainty in the rules around them — will increase the likelihood that doctors and patients use biosimilars over biologics.

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  • what is largely not understood, even by prescribers, is that each manufactured lot of any biologic is not exactly the same as another. There is unavoidable variability due to the process involved with manufacturing a biologic. Just the requirement for a biosimilar to do studies signals that they may somehow be significantly different from the originator biologic, which is both not true and also plays right into the narrative originator biologics have been telling for years in order to protect their lucrative business. It has worked (so far) and FDA is complicit. Meanwhile patients and taxpayers are having their pockets picked.

    • just to clarify the intent of the first sentence above, each lot of an originator biologic will inevitably be different from the prior one. If biosimilars need to do interchangability studies, then you can also argue that originators need to do the same with different lots. It’s silly.

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