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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announces 6 final guidance documents on gene therapy manufacturing and clinical development of products, as well as a draft guidance regarding gene therapies and orphan drugs.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.
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
