Here are the top 5 biosimilars articles for the week of June 8, 2020.
Hi, I’m Skylar Jeremias 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 June 8, 2020.
5. Downward “drift” in batches of reference trastuzumab shed more light on the importance of antibody-dependent cell-mediated cytotoxicity on survival, investigators reported at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.
4. The COVID-19 pandemic put a crimp in the FDA’s new drug and biosimilars review activities. In so doing, the pandemic helped make the case for an FDA project to upgrade its system for assessing its resource needs for biosimilar application reviews.
3. Mylan and Lupin announced that the European Commission has approved their etanercept biosimilar, Nepexto, for all indications of the reference product.
2. A recent settlement over patent challenges will enable Amgen to bring its biosimilar for eculizumab to market in 2025, giving originator company Alexion breathing space to bolster its revenue base by developing sales of a follow-on product.
1. As part of pilot program designed to improve access to cheaper medications in oncology, a rituximab biosimilar from Celltrion has been approved for use by the World Health Organization (WHO).
To read all of these articles and more, visit centerforbiosimilars.com.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Real-World Data Confirm Safety of Switching Between Ranibizumab Biosimilars
March 19th 2025Patients with diabetic macular edema previously treated with a ranibizumab biosimilar in India experience comparable safety and efficacy after being switched to another ranibizumab biosimilar, demonstrating real-world safety of biosimilar-to-biosimilar switching.
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.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
Retina Specialists’ Evolving View on Biosimilars in AMD Treatment
March 16th 2025The introduction of biosimilars in the treatment of age-related macular degeneration (AMD) is raising concerns among physicians about cost-driven mandates and the autonomy to choose the best therapies for their patients, according to Paul Hahn, MD, PhD, FASRS, a retina specialist at NJ Retina.