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The Top 5 Biosimilar Articles for the Week of November 8
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.
Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy
November 27th 2024The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.
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.
Omalizumab Biosimilar Shows Equivalent Efficacy as Multiple Sclerosis Treatment
November 26th 2024The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.
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.
Achieving PFS in Advanced Gastric Cancer With HLX02 Biosimilar, Chemotherapy
November 23rd 2024In a phase 2 study, the addition of HLX22, an anti-HER2 antibody, to HLX02 biosimilar and XELOX (oxaliplatin and capecitabine) chemotherapy extended progression-free survival (PFS) in untreated HER2-positive advanced gastric cancer patients.
