The Center for Biosimilars® recaps the top stories for the week of February 3, 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 February 3, 2020.
Number 5: The European Medicines Agency’s Committee for Medicinal Products for Human Use recommends marketing authorization for Pfizer's Ruxience, a rituximab biosimilar.
Number 4: The FDA announces 6 final guidance documents on gene therapy manufacturing and clinical development of products, as well as a draft guidance regarding gene therapies and orphan drugs.
Number 3: In an effort to speed more generic drug approvals, the FDA says it is changing how it assigns priority review status to abbreviated new drug applications.
Number 2: Celltrion recalls its employees from China’s Wuhan province until the coronavirus outbreak is brought under control.
Number 1: Merck says it is spinning off its biosimilars business to focus on its oncology drug Keytruda.
To read all of these articles and more, visit centerforbiosimilars.com.