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The Top 5 Biosimilar Articles for the Week of April 24
Here are the top 5 biosimilar articles for the week of April 24, 2023.
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 April 24, 2023.
Number 5: A study assessing factors that may determine a commercial health plan’s likelihood of covering a biosimilar found that biosimilars that are cancer therapies, used to treat children, indicated for highly prevalent conditions, or only competing against the originator were more likely to have coverage restrictions.
Number 4: Celltrion Healthcare shared data from a phase 3 clinical trial confirming that its omalizumab biosimilar had comparable safety and efficacy to the reference product (Xolair).
Number 3: A retrospective study in Scotland found that multiple successive changes from originator infliximab to biosimilars seem to be safe and effective in patients with inflammatory bowel disease (IBD), irrespective of the number of switches.
Number 2: In a complete response letter (CRL) for Alvotech, the FDA cited “deficiencies” in the company’s manufacturing facility during a reinspection, further delaying the approval for the ninth adalimumab biosimilar until potentially June 2023.
Number 1: The misconceptions about disposable bioreactors' lifecycle are gone; the era of hard-piped, giant, stainless-steel tanks for biosimilar development is history now, according to Sarfaraz K. Niazi, PhD, in his latest column.
To read all of these articles and more, visit centerforbiosimilars.com.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Biosimilars Gastroenterology Roundup: November 2024
November 30th 2024In November 2024, Skyrizi surpassed Humira as AbbVie's top seller; calls for PBM transparency and biosimilar access reforms grew; Celltrion expanded its portfolio; and Global Biosimilars Week focused on improving affordability and equity.
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.
Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy
November 27th 2024The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.
