The Center for Biosimilars recaps the top 5 articles for the week of November 27.
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 November 27.
Number 5: The World Health Organization has a released a new report that estimates that 1 in 10 drugs worldwide is either falsified or substandard, leading to unnecessary deaths and increased costs to patients and health systems.
Number 4: German drug maker Formycon projects that its biosimilar challenger to Lucentis will be launched in the US market in 2020.
Number 3: The FDA has begun to add 4-letter suffixes, devoid of meaning, to the nonproprietary names of newly approved biologics.
Number 2: Contributor Brian Lehman explains the potential impact of CMS’ proposed rule that would treat biosimilars as generic drugs for the purpose of cost-sharing under Medicare Part D.
Number 1: The FDA has approved Mylan and Biocon’s trastuzumab biosimilar, referenced on Herceptin.
Finally, last week, our e-newsletter asked whether you think that innovative device design will play a role in reference product sponsors’ defense strategies against biosimilar competition. To see results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
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.
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
February 6th 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.