The Top 5 Biosimilars Articles for the Week of February 3

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announces 6 final guidance documents on gene therapy manufacturing and clinical development of products, as well as a draft guidance regarding gene therapies and orphan drugs.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.

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