Here are the top 5 biosimilars articles for the week of May 11, 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 May 11, 2020.
Number 5: With 1 biosimilar launch and expanded indications for another biosimilar so far this year, Teva Pharmaceutical Industries reported higher biosimilar revenues in the first quarter of 2020.
Number 4: A systematic review of nonmedical-switching studies of patients with inflammatory bowel disease , also known as IBD, has detailed the knowledge gaps and study limitations responsible for this hesitation by gastroenterologists.
Number 3: Eye health business Bausch + Lomb said it has entered into an agreement to commercialize in the United States and Canada Xlucane,a ranibizumab biosimilar candidate currently under development.
Number 2: The FDA’s new focus on coronavirus disease 2019 (COVID-19) and the quarantines imposed on much of the developed world have pushed digital and remote marketing of pharmaceutical products into high gear, according to Jamie Peck, managing director of iON.
Number 1: The Federal Trade Commission was deeply divided over whether the AbbVie-Allergan $63 billion merger plan would allow for a sufficiently competitive marketplace.
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.