-
1 week ago | 
centerforbiosimilars.com | Skylar Jeremias
The FDA’s recent approvals and interchangeability designations for multiple biosimilars mark significant strides in expanding affordable treatment options for complex diseases, even as US drug pricing and global regulatory challenges underscore the urgent need for policy reform and greater biosimilar adoption.
-
1 week ago | 
ajmc.com | Skylar Jeremias
A new multi-omics and machine learning approach integrating clinical data with immune gene expression shows strong potential for accurately predicting prognosis and immunotherapy response in colorectal cancer, according to a recent analysis.1 Colorectal cancer (CRC) is one of the most common and deadly cancers worldwide, particularly in its later stages.2 While traditional tools like classic tumor lymph node metastasis (TNM) staging system are used for prognosis and treatment planning, they...
-
1 week ago | 
centerforbiosimilars.com | Skylar Jeremias
As the FDA granted interchangeable status to 2 biosimilars, Alvotech and Advanz Pharma have expanded their European biosimilar partnership to include new candidates targeting high-value biologics.
-
1 week ago | 
ajmc.com | Skylar Jeremias
One in 3 pediatric patients facing a mental health crisis who presented to the emergency department (ED) waited more than 12 hours to be admitted for transfer for further treatment between 2018 and 2022, according to recent data underscoring significant deficiencies in addressing mental health in adolescents and children.1Over the past decade, pediatric mental health ED visits have risen significantly, reflecting a growing mental health crisis among children.
-
1 week ago | 
centerforbiosimilars.com | Skylar Jeremias
A health policy in British Columbia that required biosimilar prescriptions showed no increase in hospital visits or complications, according to real-world evidence that etanercept biosimilars for inflammatory arthritis are as effective as their originator biologics without increasing hospital utilization.1 This study was conducted to address the gap between clinical trial data and real-world outcomes for biosimilars, particularly among patients newly initiating treatment for inflammatory...
-
1 week ago | 
centerforbiosimilars.com | Skylar Jeremias
The FDA has approved Starjemza (ustekinumab-hmny) as a biosimilar to Stelara (ustekinumab) for the treatment of several rheumatic and gastrointestinal conditions.1 Starjemza, developed as part of a license and commercialization agreement between Hikma Pharmaceuticals and Bio-Thera Solutions, is the eighth ustekinumab biosimilar to receive the green light from the FDA, following the approval of Steqeyma (ustekinumab-stba), which was approved in September 2024.2 "Tapping into the robust ongoing...
-
2 weeks ago | 
ajmc.com | Skylar Jeremias
The University of Pittsburgh Medical Center (UPMC) Specialty Medical Home (SMH) model is redefining care for patients with inflammatory bowel disease (IBD) and behavioral health conditions by delivering integrated, patient-centered, team-based support.1 The approach addresses the physical and psychological complexity of IBD through coordinated care that includes medical, nutritional, and behavioral health services.
-
2 weeks ago | 
centerforbiosimilars.com | Skylar Jeremias
Knowledge gaps, regulatory concerns, and cultural biases continue to hinder the adoption of generic and biosimilar medications in the Middle East and North Africa (MENA) region, underscoring the need for targeted education and policy support to empower health care professionals and promote broader acceptance, according to a study.1 “This systematic review is a pioneering effort to identify the facilitators and barriers encountered by physicians and pharmacists while implementing generic drug...
-
2 weeks ago | 
centerforbiosimilars.com | Skylar Jeremias
As the high cost of eculizumab continues to limit patient access, biosimilars offer a promising solution to improve affordability and expand treatment options for complement-mediated diseases like paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as backed by a new review showing growing biosimilar use in Europe.1 The review, published in BioDrugs, aimed to highlight the value of introducing biosimilars to eculizumab for treating PNH and aHUS—2 rare,...
-
2 weeks ago | 
ajmc.com | Skylar Jeremias
Treatment options for children with hemophilia A have expanded with the FDA approval of Bayer's Jivi antihemophilic factor (recombinant), PEGylated-aucl for the treatment of pediatric patients between 7 and 12 years of age.1 Previously, Jivi was approved in September 2018 for adults and adolescents aged 12 years and older with this hemophilia subtype.2 According to data collected from federally funded hemophilia treatment centers between 2012 and 2018, an estimated 33,000 males in the US are...
