FDA’s Gottlieb Announces Important Changes to Biosimilar and Biologic Naming

A statement by the Food and Drug Administration (FDA) departing commissioner, Scott Gottlieb, reinforced a key aspect of biosimilar naming and provided important updates to the use of four-digit suffixes for biologics and biosimilars. In his statement, Dr. Gottlieb said, “In January 2017, the FDA published a guidance document in which we sought to … Continue reading FDA’s Gottlieb Announces Important Changes to Biosimilar and Biologic Naming →

Biosimilar Bytes

In the absence of really big biosimilar stories with far-reaching implications, let’s start with some interesting bits on biosimilars to begin this week. First, insulin maker Eli Lilly asked the Food and Drug Administration a very interesting question, in comments on the agency’s guidelines on transitional drugs. Lilly requested clarification of the rules under which … Continue reading Biosimilar Bytes →

An Update From BBCIC: A Conversation With Cate Lockhart, Program Director—Part 2

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 →

More From GRx+Biosims on Four-Letter Suffixes and Biosimilar Interchangeability

The talk at the GRx+Biosims 2018 meeting this month in Baltimore was about challenges, but extrapolation was not one of them. Biosimilar interchangeability was. That was not entirely surprising. In market research projects I’ve been involved with over the past year, payers and physicians in medical groups have broadly indicated that they’ve gotten past the … Continue reading More From GRx+Biosims on Four-Letter Suffixes and Biosimilar Interchangeability →

Will the Final Guidance on Biosimilar Naming Be Reversed?

Judging from the comments at the Academy of Managed Care Pharmacy’s (AMCP’s) annual meeting March 27–30 in Denver, there is some hope and expectation that the Trump Administration will review and possibly revoke the naming convention for biologics and biosimilars that was finalized just recently.