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The Top 5 Biosimilars Articles for the Week of June 25
Here are the top 5 biosimilars articles for the week of June 25.
Transcript
Hi, I’m Samantha DiGrande 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 June 25.
Number 5: A study presented at the annual European Congress of Rheumatology found that 80% of 80 patients with rheumatic disease were willing to switch to biosimilar etanercept, and switching did not affect efficacy.
Number 4: During the American Conference Institute’s Summit on Biosimilars, experts from BIO and PhRMA provided an overview of recent policy and legislative updates in biosimilars.
Number 3: Last week, the FDA withdrew a draft guidance document on statistical approaches to evaluate analytical similarity of biosimilars after the consideration of public comments.
Number 2: A recent study has found that disease activity assessment guidelines for patients with rheumatoid arthritis have not been well evaluated in the United States.
Number 1: The American Medical Association has announced that after analyzing the proposed $69 billion dollar merger between pharmacy benefit manager CVS Health and insurer Aetna, the organization is calling for regulators to block the transaction.
To read all of these articles and more, visit centerforbiosimilars.com.
Duke Publishes Recommendations for Developing CGT Biosimilars
October 9th 2024Transformative cell and gene therapies (CGT) offer promising treatments for serious conditions, but high costs and complex biologics limit competition, requiring policies that support the development of biosimilars to enhance affordability and patient access.
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.
Treatment Persistence, Safety After Switching to Infliximab Biosimilars in Canadians With IBD
October 5th 2024A retrospective study of a mandatory nonmedical switch in Canada found no significant differences in rates of treatment persistence, loss of response, or adverse events in patients with inflammatory bowel disease (IBD) on maintenance therapy 1 year post-switch.
Biosimilar Policy Roundup—September 2024
October 1st 2024In September 2024, the FDA approved a new biosimilar for treating retinal conditions, marking a significant development in the biosimilars landscape, coinciding with ongoing legal disputes in the industry and highlighting broader trends in market dynamics and regulatory challenges.
