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The Top 5 Biosimilar Articles for the Week of May 1
Here are the top 5 biosimilar articles for the week of May 1, 2023.
Hi, I’m Justina Petrullo 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 biosimilar articles for the week of May 1st, 2023.
Number 5: Samsung Bioepis shared positive 1-year results from a phase 3 trial confirming the biosimilarity between the company’s aflibercept biosimilar and the originator (Eylea) at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting.
Number 4: In April, biosimilars to treat rheumatic conditions had some progress, as well as some setbacks, and research showed that switching from originators to biosimilars is safe and effective but warned about the nocebo effect.
Number 3: Over the past week, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.
Number 2: Nonmedical switches from Humira (reference adalimumab) to a biosimilar or an adalimumab biosimilar to another biosimilar resulted in nocebo effect responses, suggesting that more communication between providers and patients is needed, according to a real-world analysis.
Number 1: Sarfaraz K. Niazi, PhD, dove into how pharmacodynamic (PD) markers may be better than clinical efficacy testing for predicting whether a biosimilar is equally as safe and effective as its reference product, in his latest column.
To read all of these articles and more, visit centerforbiosimilars.com.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Adalimumab Biosimilar Switching Policy Shows Long-Term Success in IBD
February 26th 2025Patients with inflammatory bowel disease (IBD) who switched from reference adalimumab (Humira) to a biosimilar under a mandatory nonmedical switching policy maintained long-term safety, efficacy, and treatment persistence comparable to those who remained on the originator drug, according to a Canadian study.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Resolution of Injection Site Reactions After Switching to Adalimumab Biosimilar
February 22nd 2025A 15-year-old girl with ulcerative colitis who developed injection site reactions to the adalimumab reference product was successfully switched to the biosimilar LBAL without recurrence of symptoms, demonstrating the safety and effectiveness of switching for medical reasons, likely due to an allergic reaction to an excipient in the originator.
