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.
BioRationality: Biosimilar Associations and Stakeholders Representing Biosimilars
January 20th 2025Sarfaraz K. Niazi, PhD, dives into the role that biosimilar associations and organizations play in promoting biosimilars as well as how their stakeholder demographic and main objectives differ from one another.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Functional Similarity Between Ustekinumab Biosimilar ABP 654, Stelara in Crohn Disease
January 18th 2025Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the biosimliar's FDA approval.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Improving Biosimilar Access Through Global Regulatory Convergence
January 15th 2025Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.