"Not So Different": How the BPCIA Transition Will Affect Biosimilar Uptake
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.
Biosimilars Check-In: BI Launches Unbranded Adalimumab; New Omalizumab Deal; CRL for Insulin Aspart
October 10th 2023Boehringer Ingelheim (BI) launches an unbranded version of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partner for an omalizumab biosimilar candidate; the FDA issues a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
