The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 11.
Transcript:
Hi, I’m Kelly Davio 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 September 11.
Number 5: Poster presentations at last week’s European Society for Medical Oncology conference included the results of 5 studies on biosimilar trastuzumab candidates.
Number 4: Sandoz announced that the FDA has accepted its Biologics License Application for a proposed rituximab biosimilar.
Number 3: During a panel at the 2017 AAM Biosimilars Council Conference, regulatory leaders from Pfizer and Sandoz shared their experiences with the development of their biosimilar products.
Number 2: Dr Kashyap Patel, managing partner at Carolina Blood and Cancer Care, addresses challenges surrounding biosimilars in the US marketplace.
Number 1: This week, the FDA approved ABP 215, the first bevacizumab biosimilar.
Finally, last week, our newsletter asked you how important it is to educate patients about biosimilar treatments. To view results of the poll, visit The Center for Biosimilars® on LinkedIn.
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.