Here are the top 5 biosimilar articles for the week of November 28, 2022.
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 November 28, 2022.
Number 5: After receiving FDA approval in February 2022, Amneal Pharmaeuticals and Kashiv Biosciences launched Releuko (filgrastim-ayow) on the US market, making it the fourth biosimilar referencing Neupogen to be commercially available to Americans.
Number 4: The FDA has granted Eli Lilly’s long-acting insulin glargine biosimilar, Rezvoglar, an interchangeability designation, making it the second interchangeable insulin biosimilar in the United States.
Number 3: A new bill dubbed the Biosimilar Red Tape Elimination Act was introduced to the Senate. The bill seeks to increase patient access to biosimilars by reducing switching study requirements for getting interchangeability designations, making it easier and cheaper for corporations to establish interchangeability and patients to obtain their biologic medications.
Number 2: The VOLTAIRE-X randomized controlled trial determined the adalimumab biosimilar BI 695501 (adalimumab-adbm, Cyltezo; Boehringer Ingelheim) met the FDA’s criteria to be designated as interchangeable with the reference product (Humira).
Number 1: Iceland-based Alvotech received regulatory approval for AVT02, its biosimilar referencing Humira (adalimumab), from the Therapeutic Goods Administration of Australia.
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.