Biosimilar Pathway Not Smooth For Some Early Applicants
FDA says some candidates have appeared so different from their reference products that sponsors were told the molecule could not be a biosimilar.
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FDA will extend user fee goal dates as needed to account for the loss of two days in review cycles resulting from the government office shutdown. The extreme weather conditions led to cancellation of three advisory committees during the week of Oct. 29.
Biosimilar products are not intended to be stand-alone development programs, agency stresses, noting that early analytical data can allow for more targeted clinical trials later.
Agency officials are willing to meet with sponsors during their development programs to look at data and provide advice in part to ensure they remain on track, but also to promote a high first-cycle approval rate.