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The Top 5 Biosimilars Articles for the Week of August 21
The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 21, 2017.
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 August 21.
Number 5: Stakeholder groups, including the American College of Rheumatology and the Biotechnology Innovation Organization are praising the enactment of the FDA Reauthorization Act of 2017, calling the law critical to bringing biosimilar products to the marketplace.
Number 4: Drug maker Alexion has announced 3 new US patents that will defend its Soliris against biosimilar competition. Alexion also announced that the European Commission has granted the drug an extended indication for myasthenia gravis.
Number 3: A recently published study shows that biosimilar filgrastim is safe, effective, and well tolerated in both primary and secondary prevention of chemotherapy-induced febrile neutropenia.
Number 2: The FDA has signed an agreement to share confidential information, including trade secrets and inspection reports, with European regulators.
And Number 1: The Center for Biosimilars® Peer Exchange®, titled “Clinical Advances and Challenges with Biosimilars,” kicks off with an expert discussion of the adoption of biosimilar treatments in the United States and Europe.
Finally, last week, our newsletter asked you to share your thoughts about how the FDA should address the deficiencies it observed at Biocon’s manufacturing facility. To view results of the poll, follow The Center for Biosimilars® on LinkedIn.
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.
