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The Top 5 Biosimilar Articles for the Week of November 28
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.
Biosimilar Natalizumab-sztn Shows Comparable Efficacy and Safety to Tysabri in RRMS
March 25th 2025Biosimilar natalizumab demonstrated comparable efficacy, safety, and immunogenicity to reference drug Tysabri in patients with relapsing-remitting multiple sclerosis (RRMS), supporting its potential as a cost-effective treatment option.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Patients With IBD Maintain Therapy 2 Years Post-Switching to Infliximab Biosimilar
March 23rd 2025People with inflammatory bowel disease (IBD) who switched to the infliximab biosimilar CT-P13 had higher treatment persistence (84% and 91%) than those new to infliximab (66% and 53%), with no new safety concerns.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Real-World Data Confirm Safety of Switching Between Ranibizumab Biosimilars
March 19th 2025Patients with diabetic macular edema previously treated with a ranibizumab biosimilar in India experience comparable safety and efficacy after being switched to another ranibizumab biosimilar, demonstrating real-world safety of biosimilar-to-biosimilar switching.
