- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
The Top 5 Biosimilar Articles for the Week of October 9
Here are the top 5 biosimilar articles for the week of October 9, 2023.
Hi, I’m Justina Petrullo 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 October 9, 2023.
Number 5: Sarfaraz K. Niazi, PhD, summarized the citizen petitions he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.
Number 4: At EURETINA 2023, Samsung Bioepis shared positive comparative efficacy data on its aflibercept biosimilar candidate, demonstrating that the product is as safe and effective as the originator (Eylea).
Number 3: Boehringer Ingelheim (BI) launched an unbranded version of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partnered for an omalizumab biosimilar candidate; the FDA issued a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.
Number 2: Tofidence, a tocilizumab biosimilar developed by Biogen, will be used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
Number 1: Pfizer’s Abrilada (adalimumab-afzb) became the second biosimilar referencing Humira (adalimumab) to receive an interchangeable designation. The new label is intended to expand patient access to biosimilars.
To read all of these articles and more, visit centerforbiosimilars.com.
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?
FDA's Expanded Access: From Laetrile to Right to Try, Ethical Debates Over Early Drug Access
April 28th 2025Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA.
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.
Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market
April 25th 2025Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas.
