Here are the top 5 biosimilar articles for the week of August 10, 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 biosimilar articles for the week of August 10, 2020.
5. Sandoz Rituximab Measures Up in DLBCL
Number 5: A rituximab biosimilar in diffuse large B-cell lymphoma (DLBCL) passes the real-world test with flying colors, according to Manfred Weslau, MD.
4. Samsung Bioepis Enters Breast and Gastric Market in Brazil
Number 4: Samsung Bioepis makes a move into the promising Brazilian market for biosimilars, which data suggest is one of the fastest-growing biosimilars markets among emerging nations.
3. Samsung Bioepis Appeals to Patients Through Package Design
Number 3: In an award-winning attempt to get closer to patients, Samsung Bioepis has replaced harsh typography with white backgrounds and gentle shapes on its new biosimilar packaging.
2. Anti-TNF Biologics Outperform in Crohn Disease
Number 2: A real-world study on inflammatory bowel disease employing originator and biosimilar biologics suggests anti—tumor necrosis factor (TNF) therapy may be more effective for Crohn disease than for ulcerative colitis.
1. Cadila Puts a Teriparatide Biosimilar on the Market
Number 1: Cadila Pharmaceuticals charges ahead with yet another biosimilar launch in India, an osteoporosis agent referencing Eli Lilly's teriparatide drug Forteo.
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.