Steven Lucio Discusses BI’s Citizen Petition and the Current Status of Biosimilars

February 14, 2021

We sat down with Steven Lucio, PharmD, BCPS, senior principal of Pharmacy Solutions for Vizient, to discuss Boehringer Ingelheim's recent citizen's petition to the FDA.

In late 2020, Boehringer Ingelheim (BI) filed a citizen’s petition requesting the FDA to alter its definition of the word “strength” as used in a section of the Biologics Price Competition and Innovation Act (BPCIA). As of right now, the term is used in regard to parenteral solutions and does not allow a biological product to be licensed as a biosimilar or an interchangeable biosimilar if any variation in the volume of inactive drug content exists, even if the amount of active drug content remains consistent with the reference product.

The company argued that the current definition permits originator manufacturers to continue to develop follow-on products by only slightly changing the formulation in order to prevent biosimilar competitors from obtaining market share and goes against the goals of the BPCIA and the intention of Congress when the BPCIA was passed.

We spoke with Steven Lucio, PharmD, BCPS, vice president of Pharmacy Solutions for Vizient, to discuss his thoughts on BI’s petition and what needs to be done to advance biosimilar uptake in the United States.

To learn more about BI’s citizen petition, click here.

To hear more from Steven Lucio, PharmD, BCPS, click here.

To learn more about Vizient, click here.