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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announces 6 final guidance documents on gene therapy manufacturing and clinical development of products, as well as a draft guidance regarding gene therapies and orphan drugs.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.
To read all of these articles and more, visit centerforbiosimilars.com.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
FDA's Expanded Access: From Laetrile to Right to Try, Ethical Debates Over Early Drug Access
April 28th 2025Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA.
