This week on the podcast, we’re speaking with the executive director of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC), Cate Lockhart, PharmD, PhD, about the acceptance process for biosimilars in the United States, what BBCIC is doing to help the market develop, and how the new approval pathway for biologics will affect the pace at which biosimilars come to market.
On March 23, 2020, the transition under the Biologics Price Competition and Innovation Act (BPCIA) was complete, allowing products formerly classified as “small-molecule” drugs, including all insulin products, to be approved under the biologics regulatory pathway. This week on the podcast, we’re speaking with Cate Lockhart, executive director of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) about the acceptance process for biosimilars in the United States, what BBCIC is doing to help the market develop, and how this transition will affect the pace at which biologics come to market.
To learn more about BBCIC, visit bbcic.org.
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
Analyzing Safety of Switching From Originators to Biosimilars: A Meta-Analysis of 21 Trials
February 10th 2024The authors of a meta-analysis assessing several disease states found no significant differences in serious adverse events, deaths, or treatment discontinuations between patients who switched from reference products to biosimilars and those who did not.
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.
IQVIA Projects $192 Billion Loss for Originators by 2028 Thanks to Biosimilar, Generic Competition
January 18th 2024The IQVIA Institute for Human Data Science’s most recent Global Use of Medicines report projected that market introductions of new biosimilar and generic drugs will increase projected losses for originator products from $111 billion to $192 billion over the next 5 years.
IQVIA Report Flags Challenges With Biosimilar Access, Savings Throughout Europe
January 10th 2024IQVIA’s report on the impact biosimilar competition has had on Europe’s health care space identified ongoing challenges with biosimilar access and generating savings, calling for more policies focusing on fostering a sustainable market for years to come.