Two Biogen officials make the case for getting anti–tumor necrosis factor (TNF) biosimilars into wider play.
Anti—tumor necrosis factor (TNF) biosimilars can provide a more cost-effective, targeted approach to treatment of immune-mediated inflammatory diseases, according to a review paper.
“Along the course of the last 2 decades, TNF inhibitors, particularly etanercept, infliximab and adalimumab, have revolutionized the management of chronic immune-mediated inflammatory diseases; however, their relatively high cost prevented healthcare systems from exploiting their full clinical benefit,” Mourad F. Rezk, MD, global head of Medical Affairs for Biogen's biosimilars portfolio, and Burkhard Pieper, director of Scientific Affairs for Biogen, wrote in Advances in Therapy.
The wealth of real-world evidence on these agents suggests that not only is use increasing but also these drugs are improving access and outcomes, they explained.
“This includes the opportunity to realize clinical goals such as early initiation of biological treatment, treating to target, continuing treatment to maintain remission or low disease activity and reducing disease burden,” they wrote.
However, optimizing these biosimilars requires that biosimilars be approved “expeditiously,” competition against originator drugs is “optimized,” and patients are switched to biosimilars. “All of these actions will result in maximum cost savings, which can then be reinvested into patient care,” they wrote.
Biogen turned in a good second-quarter 2020 financial performance, with modestly improved earnings; however, biosimilar revenues declined 7%.
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.