The Center for Biosimilars® recaps the top 5 articles for the week of April 30, 2018.
Transcript:
Hi, I’m Kelly Davio 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 biosimilars articles for the week of April 30.
Number 5: Real-world evidence shows that biosimilar filgrastim has the potential to improve access to febrile neutropenia prophylaxis.
Number 4: A session at the Academy of Managed Care Pharmacy’s Managed Care & Specialty Pharmacy Annual Meeting in Boston, Massachusetts, provided an in-depth look at state legislation on biosimilars.
Number 3: Biosimilar developer Biocon has been issued a new Form 483 noting observations from an FDA inspection of its Bangalore manufacturing facility.
Number 2: Celltrion’s trastuzumab biosimilar, Herzuma, has launched in Europe, making it the second biosimilar referencing Herceptin to become available in the European marketplace.
Number 1: The FDA has issued a Complete Response Letter for Sandoz’s proposed rituximab biosimilar.
Finally, last week, our e-newsletter asked whether you think that physician education on biosimilars will improve as more products come to market.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
BioRationality: Commemorating the 15th Anniversary of the BPCIA
April 8th 2025Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Patients With IBD Maintain Therapy 2 Years Post Switching to Infliximab Biosimilar
March 23rd 2025People with inflammatory bowel disease (IBD) who switched to the infliximab biosimilar CT-P13 had higher treatment persistence (84% and 91%) than those new to infliximab (66% and 53%), with no new safety concerns.