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News and Views in Healthcare: Today's Top 3 Reads
Today's top healthcare news with a focus on the biosimilars industry.
1. Pfizer’s Humira Biosimilar Shows positive top line results: Pfizer’s second proposed inflammation biosimilar and the third proposed biosimilar pipeline molecule to report positive top-line results within the past four months.The Pfizer biosimilars pipeline consists of eight distinct biosimilar molecules in mid to late stage development, and several others in early stage development.
2. Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance: FDA will change Zarxio’s nonproprietary name from filgrastim-sndz to “filgrastim-bflm." And Amgen's Neupogen (filgrastim) would be changed to "filgrastim-jcwp."
3. FDA to review Biocon and Mylan's biosimilar drug for breast cancer: The US Food and Drug Administration (FDA) has accepted Mylan’s biologics license application (BLA) for the biosimilar, MYL-1401O, for review through the 351 (k) pathway.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Subcutaneous Infliximab CT-P13 Superior to Placebo as Maintenance Therapy for IBD
November 16th 2024In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the infliximab biosimilar CT-P13 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Breaking Down Biosimilar Barriers: Payer and PBM Policies
November 13th 2024Part 2 of this series for Global Biosimilars Week dives into the complexities of payer and pharmacy benefit manager (PBM) policies, how they impact biosimilar accessibility, and how addressing these issues may look under a second Trump term.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
