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Commentary: The Importance of Immunogenicity of Biosimilars (Video)

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.

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.

To view the video visit: http://www.ajmc.com/conferences/amcp2016/dr-jeremy-schafer-discusses-the-importance-of-immunogenicity-of-biosimilars

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.

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.