Here are the top 5 biosimilar articles for the week of November 8, 2021.
Hi, I’m Matthew Gavidia 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 November 8, 2021.
Number 5: Pfizer has indicated an intention to seek interchangeable status for its adalimumab biosimilar Abrilada, which is scheduled to launch in the United States in 2023.
Number 4: The month of October brought the second interchangeable biosimilar approval in the United States (adalimumab, Cyltezo), and Roche won FDA approval for an ocular implantable ranibizumab device, which could be a game changer in the field of ophthalmology.
Number 3: Janet Woodcock, MD, acting commissioner of the FDA, says it’s back to business for the FDA when it comes to biosimilars. COVID-19 distractions have diminished and the agency can focus on applications and factory inspections, she explains.
Number 2: Sarfaraz K. Niazi, PhD, is a member of the Advisory Board for The Center for Biosimilars® and in a column he explains one of his “biosimilar” diversions: making whiskey in the lab that tastes like the real thing, although it’s more affordable and potentially more accessible.
Number 1: Ali Ahmed, senior vice president of biosimilars for Fresenius Kabi, explains the company’s bid for a seat at the global biosimilars table. In particular, Ahmed talks about the company’s pegfilgrastim and tocilizumab biosimilar candidates, for the treatment of neutropenia and rheumatoid arthritis, respectively.
To read all of these articles and more, visit centerforbiosimilars.com.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
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.
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.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Sintilimab, Bevacizumab Biosimilar, HAIC Improves Survival in Patients With Unresectable HCC
April 14th 2024Positive results of sintilimab, IBI305, and hepatic arterial infusion chemotherapy (HAIC) treatment showed shrinking tumors and previously converting inoperable hepatocellular carcinoma (HCC) to resectable HCC with manageable adverse effects.