09/11/2024
https://www.congress.gov...
"The questions are, the guidance on the statistical approaches to analytical similarity is particularly important as it impacts initial improvability as a biosimilar under the 351K."
"Clearly you can have a little bit of wiggle room and presumably you don't want to develop that."
"There's concern that some of the manufacturing plants in India have had very poor standards."
"You told us last year in ENC though that you had a difficult time inspecting plants in India."