Wednesday, May 15, 2019

FDA puts out Biosimilars Recommendations

The FDA has released a new guidance document detailing their expectations in biosimilar development.  For anyone who has tried to read the actual regulations, these guidance documents are a massive help.  And currently, there are no approved biosimilars in the US so I'm sure this will be particularly timely.

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on policy advancements to help bring interchangeable biosimilars to market

How does this affect the ADC market?  As we mentioned last week, (Are ADCs just a fancy way to hold onto a patent?) biosimilars are coming for US Biologics, and ADCs could be an interesting path to keep a patent lasting a little longer, or to identify a new standard of care without all of the risk of a new molecule.

What do you think?  Why aren't biosimilars flodding the market as expected?

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