The Center for Biosimilars® recaps the top stories for the week of March 9, 2020.
Hi, I’m Christina Mattina 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 March 9, 2020.
Number 5: The FDA released a question-and-answer guidance for the industry about the transition coming March 23 for how certain products will be approved under a biological pathway, including exceptions to the transition and how companies will receive notifications about their applications.
Number 4: The US biosimilars market is showing healthy vital signs, said Leah Christl, Amgen’s executive director for Global Regulatory and R&D policy, while reassuring an audience that her former FDA colleagues are still champions of their work.
Number 3: The combination of growing biosimilar awareness, patent expirations, and demands to lower healthcare costs will increase uptake over the next few years, setting up some pharmaceutical firms to advance while putting others at risk, according to a recent S&P Global Ratings report.
Number 2: The FDA has granted the application for Mylan’s bevacizumab biosimilar a decision date of December 27, 2020.
Number 1: Katie Verb, director of policy and research for the biopharmaceutical industry group PhRMA, discussed recent policy changes that have increased biosimilar uptake and additional measures that could lead to greater use of biosimilars and savings for CMS and patients.
To read all of these articles and more, visit centerforbiosimilars.com.