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AMCP 2016

Dr Jeremy Schafer Discusses the Importance of Immunogenicity of Biosimilars

The FDA recently approved the biosimilar infliximab and found that from an immunogenicity profile it was more or less similar, which is important for payers and providers, explained Jeremy Schafer, PharmD, MBA, vice president and director of specialty solutions at Precision For Value.


The FDA recently approved the biosimilar infliximab and found that from an immunogenicity profile it was more or less similar, which is important for payers and providers, explained Jeremy Schafer, PharmD, MBA, vice president and director of specialty solutions at Precision For Value.

Transcript (slightly modified)

What is the most recent data on the immunogenicity of biosimilars?

I think the most recent data that will resonate most with this audience, that they’re paying the most attention to, is going to be the biosimilar infliximab that the FDA recently approved. And, in that data they found from a immunogenicity profile that it is more or less similar, and that’s going to be a very important component for any biosimilar manufacturer because I think that a lot of payers and providers are going to assume that yeah the efficacy is probably pretty similar and safety, sure, but immunogenicity: is there going to be differences? Because maybe the manufacturing was a little bit different, or some of the inert ingredients are a little bit different, and particularly if we’re thinking of changing patients from the brand to the biosimilar then immunogenicity is really going to matter.

 
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