Here are the top 5 biosimilars articles for the week of June 1, 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 1, 2020.
Number 5: Cancer drug prices are rising in the United States and Europe, but European regulators negotiate drug prices, and the results are seen in pricing trends, investigators said in a presentation for ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.
Number 4: Abstracts presented at ASCO20 Virtual revealed important data on physician prescribing of biosimilars and cost savings in the oncology space.
Number 3: The rituximab biosimilar candidate ABP 798 met primary and secondary end points for safety, efficacy, and immunogenicity in a study presented at ASCO20 Virtual.
Number 2: In a settlement announced via a Securities and Exchange Commission filing, Alexion said it had settled with Amgen over eculizumab patent disputes, allowing Amgen to bring a competing biosimilar to market in 2025.
Number 1: A study presented at ASCO20 Virtual demonstrated the power of biosimilar pegfilgrastim to lower costs in the Oncology Care Model (OCM), where pegfilgrastim expense amounts to 5.3% of the total cost of cancer care.
To read all of these articles and more, visit centerforbiosimilars.com.
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.
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.
Unifying Standards: The Need for Streamlined Biosimilar Development
October 22nd 2024At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.
Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis
October 19th 2024A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.