Here are the top 5 biosimilar articles for the week of August 2, 2021.
Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilar articles for the week of August 2, 2021.
Number 5: BioFactura said it initiated a phase 1 clinical trial for its ustekinumab biosimilar candidate (BFI-751), referencing Janssen Biotech’s blockbuster product Stelara.
Number 4: Pfizer reported strong sales for its biosimilars portfolio, but these were eclipsed by the massive success of the company's messenger RNA (mRNA) vaccine for COVID-19.
Number 3: The approval of Biocon Biologics and Viatris' insulin glargine product as an interchangeable biosimilar will be a test of whether such designations can make a difference in patient access, Jeff Baldetti, MBA, of Cardinal Health explained.
Number 2: Sarfaraz K. Niazi, PhD, discussed the regulatory approval of future mRNA vaccines, which will likely face fewer patent issues and are easy to replicate.
Number 1: The FDA approved Biocon Biologic's Semglee, an insulin glargine product, as the first interchangeable biosimilar, which is hoped to bring down the high cost of insulin.
To read all of these articles and more, visit centerforbiosimilars.com.
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
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.
Phase 1 Study Finds Comparable PK, PD Parameters in Biosimilar GP40141 vs Reference Romiplostim
November 25th 2023A phase 1 analysis confirms that romiplostim biosimilar candidate GP40141 has comparable pharmacokinetic (PK) and pharmacodynamic (PD) parameters in healthy volunteers compared with the reference product.