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Not So Different: Steven Lucio Discusses BI’s Citizen Petition and the Current Status of Biosimilars
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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.
Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients
April 9th 2024Data from 2021 and 2022 indicates increasing biosimilar use in an Italian health care company, with potential for full adoption in the future, benefiting both the National Health System and citizens through efficient and sustainable health care policies.
