Specialty Management: Keeping Up with Runaway Innovation
Contact Hours: 1.5 | Activity Type: Knowledge-based | ACPE UAN: 0233-0000-18-073-L04-P
As more biosimilar products gain FDA approval and enter the U.S. market in direct competition to the originator biologics, there is renewed uncertainty and skepticism surrounding the safety and effectiveness of these products. Even greater concern has been expressed over whether the clinical trial data on biosimilars is sufficient to support formulary decision-makers and clinicians in utilizing these new products. Of nine FDA-approved biosimilar products in the U.S., only three have been launched, and uptake has been slow. Where can we find other data sources to support treatment and coverage decisions? What post-marketing data is available for the biosimilars being used in the U.S. marketplace?
This session will describe one public-service initiative devoted to unbiased, real world, post-marketing surveillance that could contribute to the data arsenal for decision-makers and what data it has produced.
At the completion of this activity, participants should be able to: