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.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.