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1 week ago | 
centerforbiosimilars.com | Skylar Jeremias
Reimbursement policies that prioritize biosimilars over reference products have boosted trastuzumab biosimilar use in Japan’s outpatient setting, although inconsistent results across products highlight the need for more nuanced, biosimilar-specific approaches.1 Rising oncology drug costs have heavily strained health care budgets worldwide, and Japan is no exception—despite achieving nearly 80% market share for generics, largely small-molecule drugs, the country’s potential for further savings...
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1 week ago | 
ajmc.com | Skylar Jeremias
The American Society for Gastrointestinal Endoscopy (ASGE) has released updated clinical guidelines for diagnosing and managing gastroesophageal reflux disease (GERD), outlining evidence-based recommendations for endoscopic evaluation and treatment, including for patients with prior sleeve gastrectomy or peroral endoscopic myotomy.1 GERD, characterized by troublesome heartburn or regurgitation, affects about 18% to 28% of US adults, with slightly higher overall prevalence in women, and is...
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1 week ago | 
centerforbiosimilars.com | Skylar Jeremias
The office of Senator Paul (R-KY) contacted me a few weeks ago, asking how we can amend the Biologics Price Competition and Innovation Act (BPCIA) to reduce the regulatory hurdles, and requested specific language to be made as part of an amendment. I provided complete details with extensive documentary support.
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1 week ago | 
centerforbiosimilars.com | Skylar Jeremias
The US biosimilar market continued its upward trajectory in the first quarter of 2025, driven by a potent combination of regulatory reform and competitive pricing strategies. According to Samsung Bioepis’ Q2 Biosimilar Market Report,1 the FDA's evolving regulatory posture—particularly its willingness to waive phase 3 clinical trials in certain cases—is poised to reshape the biosimilar development landscape, offering both opportunities and challenges for payers and providers.
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2 weeks ago | 
centerforbiosimilars.com | Skylar Jeremias
Between congressional hearings and executive orders, experts had plenty to draw on when dissecting the barriers to biosimilar access at Festival of Biologics USA to close out April 2025.
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2 weeks ago | 
centerforbiosimilars.com | Skylar Jeremias
Adapting to market uncertainty, forging global partnerships, and rethinking traditional development strategies will be critical for future success in the biosimilar space, according to a panel of industry leaders at the Festival of Biologics USA conference in San Diego, California.1 Sharing insights from across the biosimilar pipeline, panelists included Michael Sarshad, managing director and biosimilar lead at Syneos Health Consulting; Haoheng (Sandy) Yen of Henlius USA; Sean McGowan, senior...
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2 weeks ago | 
centerforbiosimilars.com | Skylar Jeremias
A plain language summary of safety results from the VOLTAIRE clinical trials described the results of a recent pooled analysis of safety data in patients with rheumatoid arthritis (RA), Crohn disease (CD), and chronic plaque psoriasis, which found no differences in safety outcomes between adalimumab-adbm (Cyltezo) and the reference product (Humira).
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2 weeks ago | 
ajmc.com | Skylar Jeremias
Although greater coverage for glucagon-like peptide-1 receptor agonists (GLP-1 RAs) under Medicare would reduce obesity-related comorbidities, it would greatly increase Medicare spending over 10 years, according to new data published in JAMA Health Forum.1 This study was conducted to address the evolving understanding of obesity and the significant clinical potential of new antiobesity medications (AOMs), particularly GLP-1 RAs. Since obesity was recognized as a disease by the American...
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2 weeks ago | 
centerforbiosimilars.com | Skylar Jeremias
Here are the top 5 biosimilar articles for the week of April 21, 2025. Number 5: Trastuzumab biosimilars saw significant market uptake in Japan after reimbursement incentives were implemented, but bevacizumab biosimilars did not experience a similar response, according to a recent study. Number 4: Sarfaraz K.
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2 weeks ago | 
ajmc.com | Skylar Jeremias
Millions of cases of preventable infections are likely to occur over the next 25 years if child vaccination rates continue to decline, according to new research published in JAMA.1 The study utilized a simulation model to estimate the number of cases of infectious diseases that are becoming more common since vaccination rates started declining during the COVID-19 pandemic.2 According to the CDC, there are several reasons for this decline beyond stay-at-home orders associated with the pandemic...
