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Is Fairness in the Eye of the Beholder? Pfizer Citizen Petition Looking for Fair and Level Playing Field Between Biologics and Biosimilars

(FDA Law Blog) Aug 29, 2018 - An interesting Citizen Petition popped up earlier this week in which pharma giant Pfizer has requested FDA guidance on sponsor communications about biosimilar products.

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Winston Wong, PharmD (Posted: September 08, 2018)

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While there may be some truth that there is a lack of confidence with biosimilar products, I believe that the confidence level is increasing, thus not the reason for the slow uptake in utilization. I believe that the true reason for the slow uptake is due to contracting and rebate levels increasing with the reference product so that there is little motivation for any stakeholder to switch to the biosimilar product. The power of the rebate is so woven into the selection process that unless the biosimilars start to represent more significant deeper discounts than they do today, uptake will continue to be slow.

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