Mark Cziraky, PharmD, CLS: Biosimilars and Real-World Data

Mark Cziraky, PharmD, CLS, explains why real-world data are key in the biosimilars marketplace.


How important are real-world data about the safety and efficacy of biosimilars?

Yeah, I think they’re extremely important; real-world evidence and using real-world data to generate real-world evidence is extremely important in this area. Just by the nature of these therapies there is potential for some concern around their effectiveness compared to the comparative agent that they’re built from. So therefore, the fact [is] that we want to get more evidence of their use in the marketplace to show that they are reaching their intended outcomes and not showing the adverse effects that we hopefully won’t see with the products in the market.