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Pfizer's Citizen Petition on Biosimilar Communications


Gillian Woollett, MA, DPhil: Hello, and thank you for joining The Center for Biosimilars® Stakeholders Summit entitled “Provider Education on Biosimilars.” I’m Gillian Woollett, senior vice president at Avalere. Participating today on our distinguished panel are Juliana Reed, vice president, Corporate Affairs, Global Biosimilars lead at Pfizer; Carlos Sattler, MD, head of Clinical Development and Medical Affairs at Sandoz; and Kashyap Patel, MD, medical oncologist and CEO of Carolina Blood and Cancer Care. Thank you so much for joining us. Let’s begin.

So, Pfizer recently submitted to the FDA a citizen petition asking for guidance on how product sponsors can communicate about biosimilars. Why did you see the need for this citizen petition?

Juliana Reed: Thanks, Gillian. So, Pfizer saw in the marketplace educational materials and other materials created by reference product sponsors that created doubt and confusion about the safety of biosimilars. These materials, as we create the doubt and lower the confidence, will lower the uptake of biosimilars, so we felt it was necessary to file the citizen petition and ask the FDA to proactively do something about the misinformation about biosimilars in the marketplace.

Gillian Woollett, MA, DPhil: So, Carlos, does Sandoz have an opinion on both the issues raised in the citizen petition and also the ask that Pfizer has for FDA to provide additional guidance?

Carlos Sattler, MD: Thanks, Gillian. We do, we actually do. We’ve also seen a lot of misinformation out there on biosimilars. I think it’s really important to take into account the following: Healthcare providers, prescribers, must be free from any influence that inhibits them from making the best decisions for their patients. Misinformation and unbalanced information on biosimilars inhibit them from making these decisions. So we believe that something must be done, and we agree with the citizen petition. But beyond the citizen petition and the fact that it requests that guidance be authored or created by the FDA in order to take care of this misinformation, there are other steps that the FDA, we believe, can take.

For example, they could partner with a Federal Trade Commissioner and identify the sources of misinformation. They could send letters to the sources of misinformation, to the companies and others that are doing this, to tell them to stop. They could make the names of these companies and other groups that are spreading this information public so that stakeholders, patients, physicians and others know who are spreading this misinformation. And finally, they can continue with the educational efforts that they’ve embarked on but specifically addressing some of the topics of misinformation that are out there.

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