The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) is the organization that will perform the critical task of postmarketing surveillance for biosimilars and their reference biologics. Started in 2015, the BBCIC is a nonprofit, scientific public service initiative, which partners with multiple stakeholders to accomplish its mission. In the conclusion of our two-part interview with Cate … Continue reading An Update From BBCIC: A Conversation With Cate Lockhart, Program Director—Part 2
Tag: postmarketing surveillance
An Update From BBCIC: A Conversation With Cate Lockhart, Program Director—Part 1
The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) is the organization that will perform the critical task of postmarketing surveillance for biosimilars and their reference biologics. Started in 2015, the BBCIC is a nonprofit, scientific public service initiative, which partners with multiple stakeholders to accomplish its mission. In the first post of our two-part interview with … Continue reading An Update From BBCIC: A Conversation With Cate Lockhart, Program Director—Part 1
Phase 3 Studies in Biosimilars: Do They Tell Us Enough to Be Useful?
The argument for the elimination of the need for phase 3 studies in biosimilars is pretty simple: They cost a great deal but what do they add to our knowledge about the safety and efficacy of biosimilars? One of the primary tasks of the Food and Drug Administration (FDA), in educating health care professionals, media, … Continue reading Phase 3 Studies in Biosimilars: Do They Tell Us Enough to Be Useful?